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[null,"About the amendment tool:"]
[null,"•","The amendment tool may be updated from time to time. Always use the most recent version of the amendment tool available in IRAS help.  "]
[null,"•","A brief training video introducing the amendment tool and its functionality can be accessed on the HRA’s Learning Management System. You will need to register for an account in order to access the video, and we recommend that you click ‘Enrol’ before watching and click ‘Complete’ once finished to create a record of your learning."]
[null,"•","To minimise duplication, the amendment tool should be submitted in place of the Notification of Substantial Amendment form and the Non-Substantial amendment form. "]
[null,"•","A European Commission Form (Annex 2) is no longer required when notifying the MHRA of a substantial amendment to a single CTIMP. Notification to the MHRA should now include a locked pdf copy of the amendment tool. The Annex 2 form, which is available on the MHRA website, should now only be completed and submitted to the MHRA for \"bulk\" amendments, where the same change will affect many trials simultaneously."]
[null,"•","For all CTIMPs, the addition of a new NHS/HSC site and/or addition or change of a Principal Investigator (PI) in the NHS/HSC is now classified as a non-substantial change. Please note the addition of a new non-NHS/HSC site and/or addition or change of a PI at a non-NHS/HSC site on a CTIMP will continue to be classed as a substantial change."]
[null,"•","The amendment tool can be used for all amendments to all types of studies. The completed amendment tool and amended documents should be submitted as directed on the \"Submission Guidance\" tab. The amendment tool is not currently intended to be used for amendments to research tissue banks and research databases. Up to 10 individual changes can be input into the tool. "]
[null,"•","The amendment tool should be completed in order, starting with section 1. All mandatory fields (*) must be completed. The amendment tool cannot be locked for submission until all mandatory fields have been completed. The \"Glossary of Amendment Options\" tab provides a listing of all menu items to assist in identifying the right item to select when completing the tool."]
[null,"•","The Sponsor or authorised delegate is responsible for ensuring that the amendment tool is completed correctly and for comparing the outcomes against their own expectations of how the amendment should be processed. In the event of any discrepancies, the Sponsor or authorised delegate is responsible for determining the substantiality and categorisation for the amendment, and ensuring it is submitted to the relevant review bodies based on the regulations and guidance. If the Sponsor or authorised delegate is still unclear, please contact the relevant review bodies for advice."]
[null,"•","The amendment tool is not currently compliant with the Web Content Accessibility Guidelines version 2.1 AA standard for use with a screen reader. In the longer term we hope to move this over to a new digital platform and make it fully accessible. In the interim period, if you need help in accessing this"]
[null,null,"tool please email amendments@hra.nhs.uk"]
[null,"•","For queries on how to complete the tool or questions on the results from the tool, once complete, contact:"]
[null,null,"For England and Wales led studies: amendments@hra.nhs.uk"]
[null,null,"For Scotland led studies: gram.nrspcc@nhs.scot"]
[null,null,"For Northern Ireland led studies: Research.Amendments@hscni.net"]
[null,"•","If you would like to provide feedback on the amendments process, please complete the online HRA General Feedback Survey."]
[]
[]
[null,"Change record"]
[]
[null,null,"Version number",null,null,null,"Date",null,null,null,"Reason for change"]
[null,null,"1.0",null,null,null,"2020-05-15",null,null,null,"Initial release"]
[null,null,"1.1",null,null,null,"2020-05-22",null,null,null,"Updated review body requirements for \"ionising radiation exposure not involving Radioactive Substances\" options - removed ARSAC review for these changes as requested by ARSAC. Minor update to the \"Submission Guidance\" regarding submission of substantial amendments to CTIMPs in the CWoW pilot. Resolved an issue preventing the \"Lock for submission\" function from working correctly in the \"Amendment Tool\"."]
[null,null,"1.2",null,null,null,"2020-06-11",null,null,null,"\"Amendment Tool\" changes: increased the size and character limit on all free text boxes; resolved an issue affecting the Part 1/Part 2 determinations for CWoW amendments. \"Submission Guidance\" changes: clarification that category C amendments need to be submitted and may require regulatory reviews prior to implementation; updated ARSAC section to state that the completed Amendment Tool should be provided to ARSAC if their review is needed for the amendment. \"Glossary of Changes\" updates: updated the text to match the options in the \"Amendment Tool\". \"Annex 2\" changes: row headings made visible by default to make it easier to adjust the row height; added functionality to add rows to section F; included hyperlinks to the original EudraLex guidance which is referred to throughout; added option to insert digital signature image.  Corrected internal references to the \"CTIMP IMP\", \"CTIMP safety\", \"Participant Procedures\" and \"Stop or Restart\" areas which was causing some options to display incorrect outcomes. Minor formatting changes and corrections to typographical errors."]
[null,null,"1.3",null,null,null,"2020-11-17",null,null,null,"\"Amendment Tool\" changes: greatly increased character limit on all free text boxes, which now also adapt to the amount of text entered; prompt for free text aligned with the wording from the previous Notice of Substantial Amendment form to encourage completion in the same level of detail; resolved an issue in section 2 so that the questions about affected organisations appear based on the selections in section 1 for NHS/HSC and non-NHS/HSC organisations; removed most of the colours following feedback that this made it difficult to read the text; fixed calculation errors affecting the UKSW Governance and HSC Data Guardians columns; added a link to help users navigate to the online submission portal; additional guidance notes on some questions to help users select the appropriate answers. \"Submission Guidance\" updates: minor updates to the guidance for studies with multiple participating organisations in Scotland and Northern Ireland. \"Glossary of Changes\" updates: renamed to \"Glossary of Amendment Options\", updated to reflect the current options available in the tool, added some additional guidance notes. Moved and combined the \"CTIMP documents\" options with \"Study documents\" options, so all that document changes can be found together regardless of study type; updated some of the specific options to reflect REC positions more accurately."]
[null,null,"1.4",null,null,null,"2020-11-30",null,null,null,"\"Amendment Tool\" changes: fixed calculation errors affecting the REC column for outcomes after change 1."]
[null,null,"1.5",null,null,null,"2021-03-25",null,null,null,"\"Amendment Tool\" changes: the amendment tool will now be accepted by the MHRA in place of the Annex 2 form for amendments to a single CTIMP. Additional questions have been added to the amendment tool to capture all of the detail required by the MHRA; resolved an issue causing the free text boxes to not adjust correctly to the amount of text entered; resolved an issue resulting in incorrect flags for new nations in studies involving adults lacking capacity; new site and Principal Investigator changes in the NHS will now process as non-substantial changes in line with an updated policy position; added a question about whether the study involves children following feedback from RECs that this would be useful for them. \"Annex 2\" change: tab removed as the MHRA will now accept the completed amendment tool in place of the Annex 2 form for a substantial amendment to a single CTIMP."]
[null,null,"1.6",null,null,null,"2021-12-06",null,null,null,"\"Amendment Tool\" changes: replaced the radio buttons and check boxes with formatted text selections to try and resolve readability issues. Categorisation calculations updated to factor that if a change does not apply to all nations with participating NHS/HSC organisations, only some organisations are affected. Added pop-up guidance to clarify the review requirements when adding PICs for the first time, and that identical changes may be grouped together as a single entry. Added functionality to flag intended CRN portfolio status when adding NHS organisations in England to a study for the first time. Added functionality to establish whether a study in England or Wales was previously single site, self sponsored, and to prevent addition of a new site of the same type where this is the case. For changes that can either be implemented within existing resource, or that will require additional resource, the free text box will prompt for further explanation; completion of this is now mandatory to lock the tool for submission. Updated the processing for substantial IB amendments on CTIMPs so that these do not automatically route to REC - there is an expectation that if the risk/benefit assessment changes in an IB update that this will be reflected in the participant-facing documents; the tool will require a justification if substantial IB change is submitted without also updating other study documents. Added an additional prompt for non-notifiable amendments to clarify that these may still need to be shared with the participating organisations affected by the amendment. \"Submission Guidance\" updated to provide more direction in the tool and fewer weblinks; general updates and corrections to the guidance."]
[null,null,"1.7",null,null,null,"2025-03-25",null,null,null,"\"Amendment Tool\" changes: New questions added to capture whether the study involves an In Vitro Diagnostic (IVD) medical device or if this is being added by the amendment. This is to identify where this occurs and Northern Ireland is involved to signpost users to additional support as the regulations differ in Northern Ireland and Great Britain. Additional prompts in section 1 and section 4 relating to this. Updated review body requirements for ARSAC: changes to sponsor, contact details, and study closure/withdrawal - removed ARSAC review; changes to the project identifiers still need to be notified to ARSAC. Updated review body requirements for REC: change to duration of access to confidential patient information is still reviewable (e.g. by the Confidentiality Advisory Group in England and Wales) but no longer substantial for REC. Added RSI changes as an example of a significant IB update. Removed EudraCT field. Wording update to question on confidential patient information for clarity. \"Submission Guidance\" changes: added a section for IVDs in Northern Ireland. The process for notification of amendments to affected HSC organisations in Northern Ireland has been changed to align with the process in England and Wales. Updated contact details for Confidentiality Advisory Team. Updated links relating to ARSAC review. \"Glossary of Amendment Options\" updated to reflect the current options available in the tool."]
[null,null,"1.8",null,null,null,"2025-04-30",null,null,null,"Reinstated the EudraCT field removed in v1.7. Not all CTIMPs now have a EudraCT number, but it should be included where available for MHRA processing. The field is mandatory, so an answer must be given to lock the \"Amendment Tool\". Added an explanatory note that \"N/A\" can be entered if the study does not have a EudraCT number."]

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[null,"Section 1: Project information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Short project title*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$6<>\"\",1,0)","v":0}]
[null,null,"IRAS project ID* (or REC reference if no IRAS project ID is available):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,{"$f":"SUBSTITUTE($M$7,\"/\",\"-\")","v":""},null,null,null,null,{"$f":"IF($M$7<>\"\",1,0)","v":0}]
[null,null,"Sponsor amendment reference number*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$8<>\"\",1,0)","v":0}]
[null,null,"Sponsor amendment date* (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$9<>\"\",1,0)","v":0}]
[null,null,"Briefly summarise in lay language the main changes proposed in this amendment. Explain the purpose of the changes and their significance for the study. If the amendment significantly alters the research design or methodology, or could otherwise affect the scientific value of the study, supporting scientific information should be given (or enclosed separately). Indicate whether or not additional scientific critique has been obtained (note: this field will adapt to the amount of text entered)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,{"$f":"LEN($M$10)","v":0},{"$f":"COUNTIF(AW10:AW49,1)*$AI$10","v":0},{"$f":"AT49-AG10","v":3200},80,null,null,null,null,{"$f":"IF($M$10<>\"\",1,0)","v":0},null,null,null,null,1,{"$f":"AS10*$AI$10","v":80},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$10,1)),(FIND(CHAR(10),$M$10,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$10,1)),(FIND(CHAR(13),$M$10,1)),0)","v":0},{"$f":"IF(OR(AU10>0,AV10>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AW10:AW49,1),COUNTIF(AX10:AX49,1))","v":1}]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,null,null,null,null,null,8,640,0,0,0,0]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,null,null,null,null,null,10,800,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AY$10>=AS20,1,0)","v":0},null,null,null,null,null,null,null,null,null,null,null,null,null,11,880,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,12,960,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,13,1040,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,14,1120,0,{"$f":"IF(AV22=0,0,IF(ISNUMBER(FIND(CHAR(13),$M$10,SUM(1,AV22))),(FIND(CHAR(13),$M$10,SUM(1,AV22))),0))","v":0},0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,15,1200,0,{"$f":"IF(AV23=0,0,IF(ISNUMBER(FIND(CHAR(13),$M$10,SUM(1,AV23))),(FIND(CHAR(13),$M$10,SUM(1,AV23))),0))","v":0},0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,16,1280,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,17,1360,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,18,1440,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,19,1520,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,20,1600,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,21,1680,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,22,1760,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,23,1840,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,24,1920,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,25,2000,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,26,2080,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,27,2160,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,28,2240,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,29,2320,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,30,2400,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,31,2480,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,32,2560,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,33,2640,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,34,2720,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,35,2800,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,36,2880,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,37,2960,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,38,3040,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,39,3120,0,0,0,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,40,3200,{"$f":"IF(AU48=0,0,IF(ISNUMBER(FIND(CHAR(10),$M$10,SUM(1,AU48))),(FIND(CHAR(10),$M$10,SUM(1,AU48))),0))","v":0},0,0,0]
[null,null,"Project type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,"Specific study",null,null,null,null,null,null,null,null,null,null,null,null,null,1,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Research tissue bank",null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Research database",null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Has the study been reviewed by a UKECA-recognised Research Ethics Committee (REC) prior to this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50=1,1,0)","v":1},1]
[null,null,"Is review by a UKECA-recognised Research Ethics Committee (REC) being sought for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$53=1,$AF$53=2),1,0)","v":0},2]
[null,null,"What type of UKECA-recognised Research Ethics Committee (REC) review is applicable? (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,"NHS/HSC REC",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF(OR($AF$53=1,$AF$54=1),1,0))","v":1},1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Ministry of Defence (MoDREC)",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$55","v":1}]
[null,null,"Is all or part of this amendment being resubmitted to the Research Ethics Committee (REC) as a modified amendment (i.e. a substantial amendment previously given an unfavourable opinion)?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"$AE$59","v":1},2]
[null,null,"Where is the NHS/HSC Research Ethics Committee (REC) that reviewed the study based?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1,$AF$55=1),1,0)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1,$AF$55=1),1,0)","v":1},{"$f":"IF(Q59=\"Yes\",1,IF(T59=\"Yes\",2,IF(W59=\"Yes\",3,IF(Z59=\"Yes\",4,0))))","v":1}]
[null,null,"Was the study a clinical trial of an investigational medicinal product (CTIMP) OR does the amendment make it one?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},1]
[null,null,"EudraCT number* (if the study has a EudraCT number enter it here. If the study does not have a EudraCT number enter \"N/A\"):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$60=1,$AF$60=1),1,0)","v":1},null,null,null,null,null,null,null,null,{"$f":"IF($AE$61=0,1,IF($Q$61<>\"\",1,0))","v":0}]
[null,null,"Was this clinical trial of an investigational medicinal product (CTIMP) processed under the CTIMP combined review service (formerly known as the Combined Ways of Working (CWoW) pilot)?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$60=1,$AF$60=1),1,0)","v":1},2]
[null,null,"Did the study receive Pharmacy Assurance?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$60=1,$AF$60=1),1,0)","v":1},2]
[null,null,"Was the study a clinical investigation or other study of a medical device OR does the amendment make it one?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Does this clinical investigation or other study of a medical device require a Notice of No Objection from MHRA Devices?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$64=1,$AF$64=1),1,0)","v":0},2]
[null,null,"Was the study a performance evaluation study of an In Vitro Diagnostic (IVD) medical device^ (including as a companion diagnostic in a clinical trial of an investigational medicinal product)?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50=1,1,0)","v":1},2,null,null,null,{"$f":"IF(AND($AE$66=1,$AF$66=1,$AE$81=1,$AI$81=FALSE,$AE$82=1,$AI$82=TRUE),1,IF(AND($AE$66=1,$AF$66=1,$AE$87=1,$AI$87=FALSE,$AE$88=1,$AI$88=TRUE),1,0))","v":0}]
[null,null,"Does the amendment make the study a performance evaluation study of an In Vitro Diagnostic (IVD) medical device^ (including as a companion diagnostic in a clinical trial of an investigational medicinal product)?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND(AE66=1,AF66=2),1,0)","v":1},2,null,null,null,{"$f":"IF(AND($AE$67=1,$AF$67=1,$AE$82=1,$AI$82=TRUE),1,IF(AND($AE$67=1,$AF$67=1,$AE$88=1,$AI$88=TRUE),1,0))","v":0}]
[null,null,"^ IVD medical devices are tests used on biological samples, such as tissues, blood or urine, to determine the status of a person's health. This may be a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$66=1,$AE$67=1),1,0)","v":1}]
[null,null,"Did the study involve the administration of radioactive substances, therefore requiring ARSAC review, OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Did the study involve the use of research exposures to ionising radiation (not involving the administration of radioactive substances) OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Did the study have Radiation Assurance OR is Radiation Assurance being sought for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$70=1,OR($AF$69=1,$AF$70=1)),1,0)","v":0},2]
[null,null,"Did the study involve adults lacking capacity OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Does the study involve access to confidential patient information outside the direct care team without consent OR does the amendment introduce this?:\n(e.g. the study relies upon section 251 support in England and Wales, or equivalent in Scotland to set aside the common law duty of confidentiality)",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AF50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Does the study involve prisoners or young offenders who are in custody or supervised by the probation service OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AF50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Does the study involve children OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AF50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Did the study involve NHS/HSC organisations prior to this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50=1,1,0)","v":1},1]
[null,null,"Are NHS/HSC organisations being added for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF(AND($AE$76=1,$AF$76=1),0,1))","v":0},2]
[null,null,"Did the study involve non-NHS/HSC organisations OR does the amendment introduce them?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,1)","v":1},2]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"IF(OR(AE80:AE88=1),1,0)","v":1}]
[null,null,"Lead nation for the study:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1),1,IF(AND($AE$77=1,$AF$77=1),1,0))","v":1},{"$f":"IF(Q80=\"Yes\",1,IF(T80=\"Yes\",2,IF(W80=\"Yes\",3,IF(Z80=\"Yes\",4,0))))","v":1},null,null,null,"E","W","S","NI"]
[null,null,"Which nations had participating NHS/HSC organisations prior to this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"$AE$80","v":1},{"$f":"IF($Q$81=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T$81=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W$81=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z$81=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF(AND($AE$60=1,$AF$60=1),0,IF(AND($AE$72=1,$AF$72=1),1,0))","v":0},null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AF$81:$AI$81=FALSE),0,1)","v":1}]
[null,null,"Which nations will have participating NHS/HSC organisations after this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"$AE$80","v":1},{"$f":"IF($Q82=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T82=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W82=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z82=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF(AND($AJ$81=1,$AE$81=1,AF81=FALSE,OR(AF82=TRUE,AO168=1)),1,IF(AND($AJ$81=1,$AE$87=1,AF87=FALSE,OR(AF82=TRUE,AO168=1)),1,0))","v":0},{"$f":"IF(AND($AJ$81=1,$AE$81=1,AG81=FALSE,OR(AG82=TRUE,AP168=1)),1,IF(AND($AJ$81=1,$AE$87=1,AG87=FALSE,OR(AG82=TRUE,AP168=1)),1,0))","v":0},{"$f":"IF(AND($AJ$81=1,$AE$81=1,AH81=FALSE,OR(AH82=TRUE,AQ168=1)),1,IF(AND($AJ$81=1,$AE$87=1,AH87=FALSE,OR(AH82=TRUE,AQ168=1)),1,0))","v":0},{"$f":"IF(AND($AJ$81=1,$AE$81=1,AI81=FALSE,OR(AI82=TRUE,AR168=1)),1,IF(AND($AJ$81=1,$AE$87=1,AI87=FALSE,OR(AI82=TRUE,AR168=1)),1,0))","v":0},{"$f":"IF(AND($AE$77=1,$AF$77=1,$AF$82:$AI$82=FALSE),0,1)","v":1},{"$f":"IF(AND($AF$59=3,$AJ$82=1),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AK$82=1),1,0)","v":0},{"$f":"IF(AND($AF$59<>3,$AJ$81=1,AL82=1),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AM$82=1),1,0)","v":0}]
[null,null,"This amendment adds participating NHS organisations in England for the first time. Do you want the study to be considered for NIHR Clinical Research Network (CRN) Support and inclusion in the NIHR Clinical Research Network Portfolio in England?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$80=1,$AF$81=FALSE,$AF$82=TRUE),1,0)","v":0},2]
[null,null,"Was this a \"single site, self sponsored\" study in England or Wales prior to this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$80=1,OR($AG$84=\"England\",$AH$84=\"Wales\")),1,0)","v":1},1,{"$f":"IF(AND($AF$81=TRUE,$AG$81=FALSE,$AH$81=FALSE,$AI$81=FALSE),\"England\",0)","v":"England"},{"$f":"IF(AND($AF$81=FALSE,$AG$81=TRUE,$AH$81=FALSE,$AI$81=FALSE),\"Wales\",0)","v":0}]
[null,null,"Does this study only involve a single participating NHS organisation in Scotland?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,{"$f":"IF(AND($AE$80=1,$AH$85=1),1,0)","v":0},2,null,{"$f":"IF(AND($AF$81=FALSE,$AF$82=FALSE,$AG$81=FALSE,$AG$82=FALSE,$AH$81=TRUE,$AH$82=TRUE,$AI$81=FALSE,$AI$82=FALSE),1,0)","v":0}]
[null,null,"Does this study only involve a single participating HSC organisation in Northern Ireland?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,"No",null,null,null,null,null,null,null,0,2,{"$f":"IF(AND($AE$80=1,$AI$86=1),1,0)","v":0},null,{"$f":"IF(AND($AF$81=FALSE,$AF$82=FALSE,$AG$81=FALSE,$AG$82=FALSE,$AH$81=FALSE,$AH$82=FALSE,$AI$81=TRUE,$AI$82=TRUE),1,0)","v":0}]
[null,null,"Which nations had participating non-NHS/HSC organisations prior to this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1),1,0)","v":0},{"$f":"IF($Q$87=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T$87=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W$87=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z$87=\"Yes\",TRUE,FALSE)","v":false},null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,AF87:AI88=FALSE),0,1)","v":1}]
[null,null,"Which nations will have participating non-NHS/HSC organisations after this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"$AE$87","v":0},{"$f":"IF($Q88=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T88=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W88=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z88=\"Yes\",TRUE,FALSE)","v":false},null,null,null,null,null,{"$f":"IF(AND($AF$59=3,$AJ$81=1,AF87=FALSE)*OR(AF88=TRUE,AF171=TRUE,AF227=TRUE,AF283=TRUE,AF339=TRUE,AF395=TRUE,AF451=TRUE,AF507=TRUE,AF563=TRUE,AF619=TRUE,AF675=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$81=1,$AE$87=1,AG87=FALSE)*OR(AG88=TRUE,AG171=TRUE,AG227=TRUE,AG283=TRUE,AG339=TRUE,AG395=TRUE,AG451=TRUE,AG507=TRUE,AG563=TRUE,AG619=TRUE,AG675=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59<>3,$AJ$81=1,$AE$87=1,AH87=FALSE)*OR(AH88=TRUE,AH171=TRUE,AH227=TRUE,AH283=TRUE,AH339=TRUE,AH395=TRUE,AH451=TRUE,AH507=TRUE,AH563=TRUE,AH619=TRUE,AH675=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$81=1,$AE$87=1,AI87=FALSE)*OR(AI88=TRUE,AI171=TRUE,AI227=TRUE,AI283=TRUE,AI339=TRUE,AI395=TRUE,AI451=TRUE,AI507=TRUE,AI563=TRUE,AI619=TRUE,AI675=TRUE),1,0)","v":0}]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,{"$f":"IF(OR($AJ$99=1,$AK$99=1,$AL$99=1,$AM$99=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,AJ82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,AK82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,AL82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,AM82=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,{"$f":"IF(OR($AJ$100=1,$AK$100=1,$AL$100=1,$AM$100=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,$AO$82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,$AP$82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,$AQ$82=1),1,0)","v":0},{"$f":"IF(AND($AJ$81=1,$AR$82=1),1,0)","v":0}]
[null,"Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AND($AE$54=1,$AF$54=1,$AF$55=1),(AND($AE$77=1,$AF$77=1))),1,0)","v":0}]
[null,"Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing modrec@mail.dstl.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$54=1,$AF$54=1,$AF$55=2),1,0)","v":0}]
[null,"Please note: The amendment tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=2,1,0)","v":0}]
[null,"Please note: The amendment tool is not currently intended for processing amendments to research databases. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=3,1,0)","v":0}]
[null,"Please note: You should contact the HSC R&D Approvals Service for support regarding any MHRA In Vitro Diagnostic Devices submission requirements by following the instructions on the “Submission Guidance” tab.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AJ$66=1,$AJ$67=1),1,0)","v":0}]
[null,"Please note: The answers above indicate that there are no participating NHS/HSC or non-NHS/HSC organisations for this study in any of the UK nations. There must be at least one participating organisation in order to amend the study taking place there. Please check to ensure that the answers above accurately reflect the situation for the study. Sections 2-4 will not appear until at least one nation has been selected as having participating organisations.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AE101:AE104=1),0,IF(AND(AE81=0,AE82=0,AE87=0,AE88=0),1,IF(OR(AND(AE87=0,AE88=0,AE81=1,AE82=1,AF81:AI82=FALSE),AND(AE81=0,AE82=0,AE87=1,AE88=1,AF87:AI88=FALSE)),1,IF(AND(AE81=1,AE82=1,AE87=1,AE88=1,AF81:AI82=FALSE,AF87:AI88=FALSE),1,0))))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$101=1,$AE$102=1,$AE$103=1,$AE$104=1,$AE$106=1),0,IF(AND($AE$101=0,$AE$102=0,$AE$103=0,$AE$104=0,$AE$105=0,$AE$106=0),0,1))","v":0}]
[null,"Section 2: Summary of change(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$101=1,$AE$102=1,$AE$103=1,$AE$104=1,$AE$106=1),0,1)","v":1}]
[null,null,"What do you want to update?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Chief Investigator",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$62=1,$AF$62=1),1,0))","v":0},4,{"$f":"IF(OR($AE$109=1,$AE$110=1,$AE$111=1,$AE$112=1,$AE$113=1),1,0)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sponsor Group",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$109","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Administrative",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$109","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Project information",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$60=1,$AF$60=1),1,0))","v":1},null,{"$f":"IF(AND($AG$109=1,$AE$113=0),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"New site/PI only",null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$62=1,$AF$62=1),0,IF(AND($AE$60=1,$AF$60=1),1,0)))","v":1}]
[null,null,"Please note: When you are updating key project parties, you will not be able to create further amendments until the key parties are approved.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$109=1,$AF$109<3),1,0))","v":0}]
[null,null,"Please note: Only use this option when updating key contact changes for Sponsor or Legal Representatives.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$109=1,$AF$109=3),1,0))","v":0}]
[null,null,"Please note: Only use this option when adding a new site or Principal Investigator (PI) to a clinical trial of an investigational medicinal product (CTIMP). You will not be able to make any other changes at the same time.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$113=1,$AF$109=5),1,0))","v":0}]
[null,null,"Please note: Each change being made as part of the amendment must be entered separately. For example, if an amendment to a clinical trial of an investigational medicinal product (CTIMP) involves an update to the Investigator's Brochure (IB), affecting the Reference Safety Information (RSI) and so the information documents to be given to participants, these should be entered into the Amendment Tool as three separate changes. A list of all possible changes is available on the \"Glossary of Amendment Options\" tab. To add another change, click the \"Add another change\" box.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$114=0,$AE$115=0),1,0))","v":1},{"$f":"IF($AE$108=0,0,IF(AND($AE$109=0,$AE$110=0,$AE$111=0,$AE$112=0,$AE$113=0),0,IF(AND($AE$114=0,$AE$115=0,$AE$116=0),1,0)))","v":1}]
[null,null,"Change 1",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$108","v":1}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF($AE$109=0,1,IF(AND($AE$109=1,OR($AF$109=2,$AF$109=4)),1,0)))","v":1},null,{"$f":"IF($M$119=\"\",1,IF($AE$119=0,1,IF(COUNTIF(Area_18,$M$119)=1,1,0)))","v":1},{"$f":"IF(AND($AE$109=1,$AF$109=1),'Menu Data'!$A$15,IF(AND($AE$109=1,$AF$109=2),'Menu Data'!$A$19,IF(AND($AE$109=1,$AF$109=3),'Menu Data'!$A$2,$M$119)))","v":0},null,null,null,null,null,{"$f":"IF(AH119<>0,1,0)","v":0}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF($AE$109=0,1,IF(AND($AE$109=1,OR($AF$109=2,$AF$109=4)),1,0)))","v":1},{"$f":"IF($M$120=\"\",1,(IF($M$119=\"\",1,IF($AE$120=0,1,IF(COUNTIF(INDIRECT($AG$120),$M$120),1,0)))))","v":1},{"$f":"VLOOKUP($M119,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},{"$f":"IF(AND($AE$109=1,$AF$109=1),'Menu Data'!$C$107,IF(AND($AE$109=1,$AF$109=2),'Menu Data'!$C$179,IF(AND($AE$109=1,$AF$109=3),'Menu Data'!$C$6,$M$120)))","v":0},{"$f":"IF($M$120=\"\",0,IF(OR($M$120=$M$176,$M$120=$M$232,$M$120=$M$288,$M$120=$M$344,$M$120=$M$400,$M$120=$M$456,$M$120=$M$512,$M$120=$M$568,$M$120=$M$624),1,0))","v":0},{"$f":"IF(AE120=0,0,(IF(OR(M120='Menu Data'!$C$75,M120='Menu Data'!$C$77,M120='Menu Data'!$C$131,M120='Menu Data'!$C$137,M120='Menu Data'!$C$139,M120='Menu Data'!$C$159,M120='Menu Data'!$C$161),1,IF(OR(M120='Menu Data'!$C$74,M120='Menu Data'!$C$76,M120='Menu Data'!$C$132,M120='Menu Data'!$C$136,M120='Menu Data'!$C$138,M120='Menu Data'!$C$158,M120='Menu Data'!$C$160),2,IF(AE127=1,3,0)))))","v":0},{"$f":"IF($M$120=\"\",0,IF(AND($AE$55=1,$M$120='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AH120<>0,1,0)","v":0}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE120=1,M120='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE121","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE121","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE121","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE121","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE121","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ127","v":0},null,null,null,null,{"$f":"IF(AE120=0,0,(IF(M120<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$108","v":1},null,null,null,null,{"$f":"IF(AND(AJ169:AM169=FALSE,AJ225:AM225=FALSE,AJ281:AM281=FALSE,AJ337:AM337=FALSE,AJ393:AM393=FALSE,AJ449:AM449=FALSE,AJ505:AM505=FALSE,AJ561:AM561=FALSE,AJ617:AM617=FALSE,AJ673:AM673=FALSE),0,1)","v":1},null,null,null,null,{"$f":"IF(COUNTIF(AO169:AO675,1),1,0)","v":0},{"$f":"IF(COUNTIF(AP169:AP675,1),1,0)","v":0},{"$f":"IF(COUNTIF(AQ169:AQ675,1),1,0)","v":0},{"$f":"IF(COUNTIF(AR169:AR675,1),1,0)","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR(AND($AE$81=0,$AE$82=0),AND($AF$81:$AI$82=FALSE)),0,1))","v":1},{"$f":"IF($Q169=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T169=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W169=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z169=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$169=0,FALSE,$AF$169)","v":true},{"$f":"IF($AE$169=0,FALSE,$AG$169)","v":false},{"$f":"IF($AE$169=0,FALSE,$AH$169)","v":false},{"$f":"IF($AE$169=0,FALSE,$AI$169)","v":false},{"$f":"IF(AE169=0,1,IF(AND($AJ$169:$AM$171=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ169=TRUE)*OR('Amendment Tool'!$M120='Menu Data'!$C$83,'Amendment Tool'!$M120='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK169=TRUE)*OR('Amendment Tool'!$M120='Menu Data'!$C$83,'Amendment Tool'!$M120='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL169=TRUE)*OR('Amendment Tool'!$M120='Menu Data'!$C$83,'Amendment Tool'!$M120='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM169=TRUE)*OR('Amendment Tool'!$M120='Menu Data'!$C$83,'Amendment Tool'!$M120='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$169=0,0,IF(AND($AE$169=1,OR($AJ$169=TRUE,$AK$169=TRUE,$AL$169=TRUE,$AM$169=TRUE)),1,0))","v":1},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ169=FALSE),AND($AG$82=TRUE,AK169=FALSE),AND($AH$82=TRUE,AL169=FALSE),AND($AI$82=TRUE,AM169=FALSE)),2,1)","v":1},{"$f":"IF(OR(AF170=2,AG170=2),2,1)","v":1}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AE$78<>1,$AF$78<>1),0,IF(AND($AF$87:$AI$88=FALSE),0,1)))","v":0},{"$f":"IF($Q171=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T171=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W171=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z171=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$171=0,FALSE,$AF$171)","v":false},{"$f":"IF($AE$171=0,FALSE,$AG$171)","v":false},{"$f":"IF($AE$171=0,FALSE,$AH$171)","v":false},{"$f":"IF($AE$171=0,FALSE,$AI$171)","v":false},{"$f":"IF(AE171=0,1,IF(AND($AJ$169:$AM$171=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ171=TRUE)*OR('Amendment Tool'!$M168='Menu Data'!$C$83,'Amendment Tool'!$M168='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK171=TRUE)*OR('Amendment Tool'!$M168='Menu Data'!$C$83,'Amendment Tool'!$M168='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL171=TRUE)*OR('Amendment Tool'!$M168='Menu Data'!$C$83,'Amendment Tool'!$M168='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM171=TRUE)*OR('Amendment Tool'!$M168='Menu Data'!$C$83,'Amendment Tool'!$M168='Menu Data'!$C$84),1,0)","v":0}]
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[null,null,"Change 2",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$172=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$174","v":0},null,{"$f":"IF($M$175=\"\",1,IF(COUNTIF(Area_18,$M$175)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE175=0,1,IF(M175<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$174","v":0},{"$f":"IF($M$176=\"\",1,(IF($M$175=\"\",1,IF($AE$176=0,1,IF(COUNTIF(INDIRECT($AG$176),$M$176),1,0)))))","v":1},{"$f":"VLOOKUP($M175,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$176=\"\",0,IF(OR($M$176=$M$120,$M$176=$M$232,$M$176=$M$288,$M$176=$M$344,$M$176=$M$400,$M$176=$M$456,$M$176=$M$512,$M$176=$M$568,$M$176=$M$624),1,0))","v":0},{"$f":"IF(AE176=0,0,(IF(OR(M176='Menu Data'!$C$75,M176='Menu Data'!$C$77,M176='Menu Data'!$C$131,M176='Menu Data'!$C$137,M176='Menu Data'!$C$139,M176='Menu Data'!$C$159,M176='Menu Data'!$C$161),1,IF(OR(M176='Menu Data'!$C$74,M176='Menu Data'!$C$76,M176='Menu Data'!$C$132,M176='Menu Data'!$C$136,M176='Menu Data'!$C$138,M176='Menu Data'!$C$158,M176='Menu Data'!$C$160),2,IF(AE183=1,3,0)))))","v":0},{"$f":"IF($M$176=\"\",0,IF(AND($AE$55=1,$M$176='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE176=0,1,IF(M176<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE176=1,M176='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE177","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE177","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE177","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE177","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE177","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ183","v":0},null,null,null,null,{"$f":"IF(AE176=0,0,(IF(M176<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$174","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$172=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q225=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T225=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W225=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z225=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$225=0,FALSE,$AF$225)","v":false},{"$f":"IF($AE$225=0,FALSE,$AG$225)","v":false},{"$f":"IF($AE$225=0,FALSE,$AH$225)","v":false},{"$f":"IF($AE$225=0,FALSE,$AI$225)","v":false},{"$f":"IF(AE225=0,1,IF(AND($AJ$225:$AM$227=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ225=TRUE)*OR('Amendment Tool'!$M176='Menu Data'!$C$83,'Amendment Tool'!$M176='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK225=TRUE)*OR('Amendment Tool'!$M176='Menu Data'!$C$83,'Amendment Tool'!$M176='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL225=TRUE)*OR('Amendment Tool'!$M176='Menu Data'!$C$83,'Amendment Tool'!$M176='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM225=TRUE)*OR('Amendment Tool'!$M176='Menu Data'!$C$83,'Amendment Tool'!$M176='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$225=0,0,IF(AND($AE$225=1,OR($AJ$225=TRUE,$AK$225=TRUE,$AL$225=TRUE,$AM$225=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ225=FALSE),AND($AG$82=TRUE,AK225=FALSE),AND($AH$82=TRUE,AL225=FALSE),AND($AI$82=TRUE,AM225=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF226=2,AG226=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$172=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q227=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T227=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W227=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z227=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$227=0,FALSE,$AF$227)","v":false},{"$f":"IF($AE$227=0,FALSE,$AG$227)","v":false},{"$f":"IF($AE$227=0,FALSE,$AH$227)","v":false},{"$f":"IF($AE$227=0,FALSE,$AI$227)","v":false},{"$f":"IF(AE227=0,1,IF(AND($AJ$225:$AM$227=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ227=TRUE)*OR('Amendment Tool'!$M224='Menu Data'!$C$83,'Amendment Tool'!$M224='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK227=TRUE)*OR('Amendment Tool'!$M224='Menu Data'!$C$83,'Amendment Tool'!$M224='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL227=TRUE)*OR('Amendment Tool'!$M224='Menu Data'!$C$83,'Amendment Tool'!$M224='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM227=TRUE)*OR('Amendment Tool'!$M224='Menu Data'!$C$83,'Amendment Tool'!$M224='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AH228","v":"Add another change"},null,null,null,null,null,null,null,{"$f":"$AE$174","v":0},false,{"$f":"IF($AE$228=0,FALSE,$AF$228)","v":false},{"$f":"IF(AG228=TRUE,\"Remove all changes below\",\"Add another change\")","v":"Add another change"}]
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[null,null,"Change 3",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$228=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$230","v":0},null,{"$f":"IF($M$231=\"\",1,IF(COUNTIF(Area_18,$M$231)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE231=0,1,IF(M231<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$230","v":0},{"$f":"IF($M$232=\"\",1,(IF($M$231=\"\",1,IF($AE$232=0,1,IF(COUNTIF(INDIRECT($AG$232),$M$232),1,0)))))","v":1},{"$f":"VLOOKUP($M231,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$232=\"\",0,IF(OR($M$232=$M$120,$M$232=$M$176,$M$232=$M$288,$M$232=$M$344,$M$232=$M$400,$M$232=$M$456,$M$232=$M$512,$M$232=$M$568,$M$232=$M$624),1,0))","v":0},{"$f":"IF(AE232=0,0,(IF(OR(M232='Menu Data'!$C$75,M232='Menu Data'!$C$77,M232='Menu Data'!$C$131,M232='Menu Data'!$C$137,M232='Menu Data'!$C$139,M232='Menu Data'!$C$159,M232='Menu Data'!$C$161),1,IF(OR(M232='Menu Data'!$C$74,M232='Menu Data'!$C$76,M232='Menu Data'!$C$132,M232='Menu Data'!$C$136,M232='Menu Data'!$C$138,M232='Menu Data'!$C$158,M232='Menu Data'!$C$160),2,IF(AE239=1,3,0)))))","v":0},{"$f":"IF($M$232=\"\",0,IF(AND($AE$55=1,$M$232='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE232=0,1,IF(M232<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE232=1,M232='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE233","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE233","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE233","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE233","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE233","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ239","v":0},null,null,null,null,{"$f":"IF(AE232=0,0,(IF(M232<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$230","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$228=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q281=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T281=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W281=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z281=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$281=0,FALSE,$AF$281)","v":false},{"$f":"IF($AE$281=0,FALSE,$AG$281)","v":false},{"$f":"IF($AE$281=0,FALSE,$AH$281)","v":false},{"$f":"IF($AE$281=0,FALSE,$AI$281)","v":false},{"$f":"IF(AE281=0,1,IF(AND($AJ$281:$AM$283=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ281=TRUE)*OR('Amendment Tool'!$M232='Menu Data'!$C$83,'Amendment Tool'!$M232='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK281=TRUE)*OR('Amendment Tool'!$M232='Menu Data'!$C$83,'Amendment Tool'!$M232='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL281=TRUE)*OR('Amendment Tool'!$M232='Menu Data'!$C$83,'Amendment Tool'!$M232='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM281=TRUE)*OR('Amendment Tool'!$M232='Menu Data'!$C$83,'Amendment Tool'!$M232='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$281=0,0,IF(AND($AE$281=1,OR($AJ$281=TRUE,$AK$281=TRUE,$AL$281=TRUE,$AM$281=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ281=FALSE),AND($AG$82=TRUE,AK281=FALSE),AND($AH$82=TRUE,AL281=FALSE),AND($AI$82=TRUE,AM281=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF282=2,AG282=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$228=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q283=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T283=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W283=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z283=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$283=0,FALSE,$AF$283)","v":false},{"$f":"IF($AE$283=0,FALSE,$AG$283)","v":false},{"$f":"IF($AE$283=0,FALSE,$AH$283)","v":false},{"$f":"IF($AE$283=0,FALSE,$AI$283)","v":false},{"$f":"IF(AE283=0,1,IF(AND($AJ$281:$AM$283=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ283=TRUE)*OR('Amendment Tool'!$M280='Menu Data'!$C$83,'Amendment Tool'!$M280='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK283=TRUE)*OR('Amendment Tool'!$M280='Menu Data'!$C$83,'Amendment Tool'!$M280='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL283=TRUE)*OR('Amendment Tool'!$M280='Menu Data'!$C$83,'Amendment Tool'!$M280='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM283=TRUE)*OR('Amendment Tool'!$M280='Menu Data'!$C$83,'Amendment Tool'!$M280='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AH284","v":"Add another change"},null,null,null,null,null,null,null,{"$f":"$AE$230","v":0},false,{"$f":"IF($AE$284=0,FALSE,$AF$284)","v":false},{"$f":"IF(AG284=TRUE,\"Remove all changes below\",\"Add another change\")","v":"Add another change"}]
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[null,null,"Change 4",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$284=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$286","v":0},null,{"$f":"IF($M$287=\"\",1,IF(COUNTIF(Area_18,$M$287)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE287=0,1,IF(M287<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$286","v":0},{"$f":"IF($M$288=\"\",1,(IF($M$287=\"\",1,IF($AE$288=0,1,IF(COUNTIF(INDIRECT($AG$288),$M$288),1,0)))))","v":1},{"$f":"VLOOKUP($M287,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$288=\"\",0,IF(OR($M$288=$M$120,$M$288=$M$176,$M$288=$M$232,$M$288=$M$344,$M$288=$M$400,$M$288=$M$456,$M$288=$M$512,$M$288=$M$568,$M$288=$M$624),1,0))","v":0},{"$f":"IF(AE288=0,0,(IF(OR(M288='Menu Data'!$C$75,M288='Menu Data'!$C$77,M288='Menu Data'!$C$131,M288='Menu Data'!$C$137,M288='Menu Data'!$C$139,M288='Menu Data'!$C$159,M288='Menu Data'!$C$161),1,IF(OR(M288='Menu Data'!$C$74,M288='Menu Data'!$C$76,M288='Menu Data'!$C$132,M288='Menu Data'!$C$136,M288='Menu Data'!$C$138,M288='Menu Data'!$C$158,M288='Menu Data'!$C$160),2,IF(AE295=1,3,0)))))","v":0},{"$f":"IF($M$288=\"\",0,IF(AND($AE$55=1,$M$288='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE288=0,1,IF(M288<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE288=1,M288='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE289","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE289","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE289","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE289","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE289","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ295","v":0},null,null,null,null,{"$f":"IF(AE288=0,0,(IF(M288<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$286","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$284=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q337=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T337=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W337=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z337=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$337=0,FALSE,$AF$337)","v":false},{"$f":"IF($AE$337=0,FALSE,$AG$337)","v":false},{"$f":"IF($AE$337=0,FALSE,$AH$337)","v":false},{"$f":"IF($AE$337=0,FALSE,$AI$337)","v":false},{"$f":"IF(AE337=0,1,IF(AND($AJ$337:$AM$339=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ337=TRUE)*OR('Amendment Tool'!$M288='Menu Data'!$C$83,'Amendment Tool'!$M288='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK337=TRUE)*OR('Amendment Tool'!$M288='Menu Data'!$C$83,'Amendment Tool'!$M288='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL337=TRUE)*OR('Amendment Tool'!$M288='Menu Data'!$C$83,'Amendment Tool'!$M288='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM337=TRUE)*OR('Amendment Tool'!$M288='Menu Data'!$C$83,'Amendment Tool'!$M288='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$337=0,0,IF(AND($AE$337=1,OR($AJ$337=TRUE,$AK$337=TRUE,$AL$337=TRUE,$AM$337=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ337=FALSE),AND($AG$82=TRUE,AK337=FALSE),AND($AH$82=TRUE,AL337=FALSE),AND($AI$82=TRUE,AM337=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF338=2,AG338=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$284=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q339=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T339=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W339=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z339=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$339=0,FALSE,$AF$339)","v":false},{"$f":"IF($AE$339=0,FALSE,$AG$339)","v":false},{"$f":"IF($AE$339=0,FALSE,$AH$339)","v":false},{"$f":"IF($AE$339=0,FALSE,$AI$339)","v":false},{"$f":"IF(AE339=0,1,IF(AND($AJ$337:$AM$339=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ339=TRUE)*OR('Amendment Tool'!$M336='Menu Data'!$C$83,'Amendment Tool'!$M336='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK339=TRUE)*OR('Amendment Tool'!$M336='Menu Data'!$C$83,'Amendment Tool'!$M336='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL339=TRUE)*OR('Amendment Tool'!$M336='Menu Data'!$C$83,'Amendment Tool'!$M336='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM339=TRUE)*OR('Amendment Tool'!$M336='Menu Data'!$C$83,'Amendment Tool'!$M336='Menu Data'!$C$84),1,0)","v":0}]
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[null,null,"Change 5",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$340=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$342","v":0},null,{"$f":"IF($M$343=\"\",1,IF(COUNTIF(Area_18,$M$343)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE343=0,1,IF(M343<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$342","v":0},{"$f":"IF($M$344=\"\",1,(IF($M$343=\"\",1,IF($AE$344=0,1,IF(COUNTIF(INDIRECT($AG$344),$M$344),1,0)))))","v":1},{"$f":"VLOOKUP($M343,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$344=\"\",0,IF(OR($M$344=$M$120,$M$344=$M$176,$M$344=$M$232,$M$344=$M$288,$M$344=$M$400,$M$344=$M$456,$M$344=$M$512,$M$344=$M$568,$M$344=$M$624),1,0))","v":0},{"$f":"IF(AE344=0,0,(IF(OR(M344='Menu Data'!$C$75,M344='Menu Data'!$C$77,M344='Menu Data'!$C$131,M344='Menu Data'!$C$137,M344='Menu Data'!$C$139,M344='Menu Data'!$C$159,M344='Menu Data'!$C$161),1,IF(OR(M344='Menu Data'!$C$74,M344='Menu Data'!$C$76,M344='Menu Data'!$C$132,M344='Menu Data'!$C$136,M344='Menu Data'!$C$138,M344='Menu Data'!$C$158,M344='Menu Data'!$C$160),2,IF(AE351=1,3,0)))))","v":0},{"$f":"IF($M$344=\"\",0,IF(AND($AE$55=1,$M$344='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE344=0,1,IF(M344<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE344=1,M344='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE345","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE345","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE345","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE345","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE345","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ351","v":0},null,null,null,null,{"$f":"IF(AE344=0,0,(IF(M344<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$342","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$340=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q393=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T393=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W393=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z393=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$393=0,FALSE,$AF$393)","v":false},{"$f":"IF($AE$393=0,FALSE,$AG$393)","v":false},{"$f":"IF($AE$393=0,FALSE,$AH$393)","v":false},{"$f":"IF($AE$393=0,FALSE,$AI$393)","v":false},{"$f":"IF(AE393=0,1,IF(AND($AJ$393:$AM$395=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ393=TRUE)*OR('Amendment Tool'!$M344='Menu Data'!$C$83,'Amendment Tool'!$M344='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK393=TRUE)*OR('Amendment Tool'!$M344='Menu Data'!$C$83,'Amendment Tool'!$M344='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL393=TRUE)*OR('Amendment Tool'!$M344='Menu Data'!$C$83,'Amendment Tool'!$M344='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM393=TRUE)*OR('Amendment Tool'!$M344='Menu Data'!$C$83,'Amendment Tool'!$M344='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$393=0,0,IF(AND($AE$393=1,OR($AJ$393=TRUE,$AK$393=TRUE,$AL$393=TRUE,$AM$393=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ393=FALSE),AND($AG$82=TRUE,AK393=FALSE),AND($AH$82=TRUE,AL393=FALSE),AND($AI$82=TRUE,AM393=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF394=2,AG394=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$340=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q395=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T395=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W395=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z395=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$395=0,FALSE,$AF$395)","v":false},{"$f":"IF($AE$395=0,FALSE,$AG$395)","v":false},{"$f":"IF($AE$395=0,FALSE,$AH$395)","v":false},{"$f":"IF($AE$395=0,FALSE,$AI$395)","v":false},{"$f":"IF(AE395=0,1,IF(AND($AJ$393:$AM$395=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ395=TRUE)*OR('Amendment Tool'!$M392='Menu Data'!$C$83,'Amendment Tool'!$M392='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK395=TRUE)*OR('Amendment Tool'!$M392='Menu Data'!$C$83,'Amendment Tool'!$M392='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL395=TRUE)*OR('Amendment Tool'!$M392='Menu Data'!$C$83,'Amendment Tool'!$M392='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM395=TRUE)*OR('Amendment Tool'!$M392='Menu Data'!$C$83,'Amendment Tool'!$M392='Menu Data'!$C$84),1,0)","v":0}]
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[null,null,"Change 6",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$396=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$398","v":0},null,{"$f":"IF($M$399=\"\",1,IF(COUNTIF(Area_18,$M$399)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE399=0,1,IF(M399<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$398","v":0},{"$f":"IF($M$400=\"\",1,(IF($M$399=\"\",1,IF($AE$400=0,1,IF(COUNTIF(INDIRECT($AG$400),$M$400),1,0)))))","v":1},{"$f":"VLOOKUP($M399,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$400=\"\",0,IF(OR($M$400=$M$120,$M$400=$M$176,$M$400=$M$232,$M$400=$M$288,$M$400=$M$344,$M$400=$M$456,$M$400=$M$512,$M$400=$M$568,$M$400=$M$624),1,0))","v":0},{"$f":"IF(AE400=0,0,(IF(OR(M400='Menu Data'!$C$75,M400='Menu Data'!$C$77,M400='Menu Data'!$C$131,M400='Menu Data'!$C$137,M400='Menu Data'!$C$139,M400='Menu Data'!$C$159,M400='Menu Data'!$C$161),1,IF(OR(M400='Menu Data'!$C$74,M400='Menu Data'!$C$76,M400='Menu Data'!$C$132,M400='Menu Data'!$C$136,M400='Menu Data'!$C$138,M400='Menu Data'!$C$158,M400='Menu Data'!$C$160),2,IF(AE407=1,3,0)))))","v":0},{"$f":"IF($M$400=\"\",0,IF(AND($AE$55=1,$M$400='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE400=0,1,IF(M400<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE400=1,M400='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE401","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE401","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE401","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE401","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE401","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ407","v":0},null,null,null,null,{"$f":"IF(AE400=0,0,(IF(M400<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
[null,null,{"$f":"AJ408","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$398","v":0},{"$f":"LEN($M$408)","v":0},{"$f":"COUNTIF(AW408:AW447,1)*$AI$408","v":0},{"$f":"AT447-AG408","v":3200},80,{"$f":"CONCATENATE(\"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers\",AK408)","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ400=1,\". In particular, please describe the additional resource arrangements that participating organisations will need to have in place to implement this change (free text - note that this field will adapt to the amount of text entered)*:\",IF(AJ400=2,\". In particular, please describe why this change can be implemented within the existing resource in place at the participating organisations (free text - note that this field will adapt to the amount of text entered)*\",IF(AJ400=3,\" (free text - note that this field will adapt to the amount of text entered)*:\",\" (free text - note that this field will adapt to the amount of text entered):\")))","v":" (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ400=2,\"In particular, please describe the additional resource arrangements that participating organisations will need to implement this change*\",\"\")","v":""},null,{"$f":"IF(OR(AE408=0,AJ400=0),1,IF(M408<>0,1,0))","v":1},null,null,null,null,1,{"$f":"AS408*$AI$408","v":80},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$408,1)),(FIND(CHAR(10),$M$408,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$408,1)),(FIND(CHAR(13),$M$408,1)),0)","v":0},{"$f":"IF(OR(AU408>0,AV408>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AW408:AW447,1),COUNTIF(AX408:AX447,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$396=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q449=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T449=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W449=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z449=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$449=0,FALSE,$AF$449)","v":false},{"$f":"IF($AE$449=0,FALSE,$AG$449)","v":false},{"$f":"IF($AE$449=0,FALSE,$AH$449)","v":false},{"$f":"IF($AE$449=0,FALSE,$AI$449)","v":false},{"$f":"IF(AE449=0,1,IF(AND($AJ$449:$AM$451=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ449=TRUE)*OR('Amendment Tool'!$M400='Menu Data'!$C$83,'Amendment Tool'!$M400='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK449=TRUE)*OR('Amendment Tool'!$M400='Menu Data'!$C$83,'Amendment Tool'!$M400='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL449=TRUE)*OR('Amendment Tool'!$M400='Menu Data'!$C$83,'Amendment Tool'!$M400='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM449=TRUE)*OR('Amendment Tool'!$M400='Menu Data'!$C$83,'Amendment Tool'!$M400='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$449=0,0,IF(AND($AE$449=1,OR($AJ$449=TRUE,$AK$449=TRUE,$AL$449=TRUE,$AM$449=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ449=FALSE),AND($AG$82=TRUE,AK449=FALSE),AND($AH$82=TRUE,AL449=FALSE),AND($AI$82=TRUE,AM449=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF450=2,AG450=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$396=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q451=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T451=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W451=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z451=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$451=0,FALSE,$AF$451)","v":false},{"$f":"IF($AE$451=0,FALSE,$AG$451)","v":false},{"$f":"IF($AE$451=0,FALSE,$AH$451)","v":false},{"$f":"IF($AE$451=0,FALSE,$AI$451)","v":false},{"$f":"IF(AE451=0,1,IF(AND($AJ$449:$AM$451=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ451=TRUE)*OR('Amendment Tool'!$M448='Menu Data'!$C$83,'Amendment Tool'!$M448='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK451=TRUE)*OR('Amendment Tool'!$M448='Menu Data'!$C$83,'Amendment Tool'!$M448='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL451=TRUE)*OR('Amendment Tool'!$M448='Menu Data'!$C$83,'Amendment Tool'!$M448='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM451=TRUE)*OR('Amendment Tool'!$M448='Menu Data'!$C$83,'Amendment Tool'!$M448='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AH452","v":"Add another change"},null,null,null,null,null,null,null,{"$f":"$AE$398","v":0},false,{"$f":"IF($AE$452=0,FALSE,$AF$452)","v":false},{"$f":"IF(AG452=TRUE,\"Remove all changes below\",\"Add another change\")","v":"Add another change"}]
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[null,null,"Change 7",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$452=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$454","v":0},null,{"$f":"IF($M$455=\"\",1,IF(COUNTIF(Area_18,$M$455)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE455=0,1,IF(M455<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$454","v":0},{"$f":"IF($M$456=\"\",1,(IF($M$455=\"\",1,IF($AE$456=0,1,IF(COUNTIF(INDIRECT($AG$456),$M$456),1,0)))))","v":1},{"$f":"VLOOKUP($M455,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$456=\"\",0,IF(OR($M$456=$M$120,$M$456=$M$176,$M$456=$M$232,$M$456=$M$288,$M$456=$M$344,$M$456=$M$400,$M$456=$M$512,$M$456=$M$568,$M$456=$M$624),1,0))","v":0},{"$f":"IF(AE456=0,0,(IF(OR(M456='Menu Data'!$C$75,M456='Menu Data'!$C$77,M456='Menu Data'!$C$131,M456='Menu Data'!$C$137,M456='Menu Data'!$C$139,M456='Menu Data'!$C$159,M456='Menu Data'!$C$161),1,IF(OR(M456='Menu Data'!$C$74,M456='Menu Data'!$C$76,M456='Menu Data'!$C$132,M456='Menu Data'!$C$136,M456='Menu Data'!$C$138,M456='Menu Data'!$C$158,M456='Menu Data'!$C$160),2,IF(AE463=1,3,0)))))","v":0},{"$f":"IF($M$456=\"\",0,IF(AND($AE$55=1,$M$456='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE456=0,1,IF(M456<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE456=1,M456='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE457","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE457","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE457","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE457","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE457","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ463","v":0},null,null,null,null,{"$f":"IF(AE456=0,0,(IF(M456<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$452=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q505=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T505=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W505=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z505=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$505=0,FALSE,$AF$505)","v":false},{"$f":"IF($AE$505=0,FALSE,$AG$505)","v":false},{"$f":"IF($AE$505=0,FALSE,$AH$505)","v":false},{"$f":"IF($AE$505=0,FALSE,$AI$505)","v":false},{"$f":"IF(AE505=0,1,IF(AND($AJ$505:$AM$507=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ505=TRUE)*OR('Amendment Tool'!$M456='Menu Data'!$C$83,'Amendment Tool'!$M456='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK505=TRUE)*OR('Amendment Tool'!$M456='Menu Data'!$C$83,'Amendment Tool'!$M456='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL505=TRUE)*OR('Amendment Tool'!$M456='Menu Data'!$C$83,'Amendment Tool'!$M456='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM505=TRUE)*OR('Amendment Tool'!$M456='Menu Data'!$C$83,'Amendment Tool'!$M456='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$505=0,0,IF(AND($AE$505=1,OR($AJ$505=TRUE,$AK$505=TRUE,$AL$505=TRUE,$AM$505=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ505=FALSE),AND($AG$82=TRUE,AK505=FALSE),AND($AH$82=TRUE,AL505=FALSE),AND($AI$82=TRUE,AM505=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF506=2,AG506=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$452=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q507=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T507=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W507=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z507=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$507=0,FALSE,$AF$507)","v":false},{"$f":"IF($AE$507=0,FALSE,$AG$507)","v":false},{"$f":"IF($AE$507=0,FALSE,$AH$507)","v":false},{"$f":"IF($AE$507=0,FALSE,$AI$507)","v":false},{"$f":"IF(AE507=0,1,IF(AND($AJ$505:$AM$507=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ507=TRUE)*OR('Amendment Tool'!$M504='Menu Data'!$C$83,'Amendment Tool'!$M504='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK507=TRUE)*OR('Amendment Tool'!$M504='Menu Data'!$C$83,'Amendment Tool'!$M504='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL507=TRUE)*OR('Amendment Tool'!$M504='Menu Data'!$C$83,'Amendment Tool'!$M504='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM507=TRUE)*OR('Amendment Tool'!$M504='Menu Data'!$C$83,'Amendment Tool'!$M504='Menu Data'!$C$84),1,0)","v":0}]
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[null,null,"Change 8",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$508=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$510","v":0},null,{"$f":"IF($M$511=\"\",1,IF(COUNTIF(Area_18,$M$511)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE511=0,1,IF(M511<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$510","v":0},{"$f":"IF($M$512=\"\",1,(IF($M$511=\"\",1,IF($AE$512=0,1,IF(COUNTIF(INDIRECT($AG$512),$M$512),1,0)))))","v":1},{"$f":"VLOOKUP($M511,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$512=\"\",0,IF(OR($M$512=$M$120,$M$512=$M$176,$M$512=$M$232,$M$512=$M$288,$M$512=$M$344,$M$512=$M$400,$M$512=$M$456,$M$512=$M$568,$M$512=$M$624),1,0))","v":0},{"$f":"IF(AE512=0,0,(IF(OR(M512='Menu Data'!$C$75,M512='Menu Data'!$C$77,M512='Menu Data'!$C$131,M512='Menu Data'!$C$137,M512='Menu Data'!$C$139,M512='Menu Data'!$C$159,M512='Menu Data'!$C$161),1,IF(OR(M512='Menu Data'!$C$74,M512='Menu Data'!$C$76,M512='Menu Data'!$C$132,M512='Menu Data'!$C$136,M512='Menu Data'!$C$138,M512='Menu Data'!$C$158,M512='Menu Data'!$C$160),2,IF(AE519=1,3,0)))))","v":0},{"$f":"IF($M$512=\"\",0,IF(AND($AE$55=1,$M$512='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE512=0,1,IF(M512<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE512=1,M512='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE513","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE513","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE513","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE513","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE513","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ519","v":0},null,null,null,null,{"$f":"IF(AE512=0,0,(IF(M512<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
[null,null,{"$f":"AJ520","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$510","v":0},{"$f":"LEN($M$520)","v":0},{"$f":"COUNTIF(AW520:AW559,1)*$AI$520","v":0},{"$f":"AT559-AG520","v":3200},80,{"$f":"CONCATENATE(\"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers\",AK520)","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ512=1,\". In particular, please describe the additional resource arrangements that participating organisations will need to have in place to implement this change (free text - note that this field will adapt to the amount of text entered)*:\",IF(AJ512=2,\". In particular, please describe why this change can be implemented within the existing resource in place at the participating organisations (free text - note that this field will adapt to the amount of text entered)*\",IF(AJ512=3,\" (free text - note that this field will adapt to the amount of text entered)*:\",\" (free text - note that this field will adapt to the amount of text entered):\")))","v":" (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ512=2,\"In particular, please describe the additional resource arrangements that participating organisations will need to implement this change*\",\"\")","v":""},null,{"$f":"IF(OR(AE520=0,AJ512=0),1,IF(M520<>0,1,0))","v":1},null,null,null,null,1,{"$f":"AS520*$AI$520","v":80},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$520,1)),(FIND(CHAR(10),$M$520,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$520,1)),(FIND(CHAR(13),$M$520,1)),0)","v":0},{"$f":"IF(OR(AU520>0,AV520>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AW520:AW559,1),COUNTIF(AX520:AX559,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$508=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q561=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T561=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W561=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z561=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$561=0,FALSE,$AF$561)","v":false},{"$f":"IF($AE$561=0,FALSE,$AG$561)","v":false},{"$f":"IF($AE$561=0,FALSE,$AH$561)","v":false},{"$f":"IF($AE$561=0,FALSE,$AI$561)","v":false},{"$f":"IF(AE561=0,1,IF(AND($AJ$561:$AM$563=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ561=TRUE)*OR('Amendment Tool'!$M512='Menu Data'!$C$83,'Amendment Tool'!$M512='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK561=TRUE)*OR('Amendment Tool'!$M512='Menu Data'!$C$83,'Amendment Tool'!$M512='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL561=TRUE)*OR('Amendment Tool'!$M512='Menu Data'!$C$83,'Amendment Tool'!$M512='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM561=TRUE)*OR('Amendment Tool'!$M512='Menu Data'!$C$83,'Amendment Tool'!$M512='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$561=0,0,IF(AND($AE$561=1,OR($AJ$561=TRUE,$AK$561=TRUE,$AL$561=TRUE,$AM$561=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ561=FALSE),AND($AG$82=TRUE,AK561=FALSE),AND($AH$82=TRUE,AL561=FALSE),AND($AI$82=TRUE,AM561=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF562=2,AG562=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$508=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q563=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T563=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W563=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z563=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$563=0,FALSE,$AF$563)","v":false},{"$f":"IF($AE$563=0,FALSE,$AG$563)","v":false},{"$f":"IF($AE$563=0,FALSE,$AH$563)","v":false},{"$f":"IF($AE$563=0,FALSE,$AI$563)","v":false},{"$f":"IF(AE563=0,1,IF(AND($AJ$561:$AM$563=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ563=TRUE)*OR('Amendment Tool'!$M560='Menu Data'!$C$83,'Amendment Tool'!$M560='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK563=TRUE)*OR('Amendment Tool'!$M560='Menu Data'!$C$83,'Amendment Tool'!$M560='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL563=TRUE)*OR('Amendment Tool'!$M560='Menu Data'!$C$83,'Amendment Tool'!$M560='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM563=TRUE)*OR('Amendment Tool'!$M560='Menu Data'!$C$83,'Amendment Tool'!$M560='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AH564","v":"Add another change"},null,null,null,null,null,null,null,{"$f":"$AE$510","v":0},false,{"$f":"IF($AE$564=0,FALSE,$AF$564)","v":false},{"$f":"IF(AG564=TRUE,\"Remove all changes below\",\"Add another change\")","v":"Add another change"}]
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[null,null,"Change 9",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$564=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$566","v":0},null,{"$f":"IF($M$567=\"\",1,IF(COUNTIF(Area_18,$M$567)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE567=0,1,IF(M567<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$566","v":0},{"$f":"IF($M$568=\"\",1,(IF($M$567=\"\",1,IF($AE$568=0,1,IF(COUNTIF(INDIRECT($AG$568),$M$568),1,0)))))","v":1},{"$f":"VLOOKUP($M567,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$568=\"\",0,IF(OR($M$568=$M$120,$M$568=$M$176,$M$568=$M$232,$M$568=$M$288,$M$568=$M$344,$M$568=$M$400,$M$568=$M$456,$M$568=$M$512,$M$568=$M$624),1,0))","v":0},{"$f":"IF(AE568=0,0,(IF(OR(M568='Menu Data'!$C$75,M568='Menu Data'!$C$77,M568='Menu Data'!$C$131,M568='Menu Data'!$C$137,M568='Menu Data'!$C$139,M568='Menu Data'!$C$159,M568='Menu Data'!$C$161),1,IF(OR(M568='Menu Data'!$C$74,M568='Menu Data'!$C$76,M568='Menu Data'!$C$132,M568='Menu Data'!$C$136,M568='Menu Data'!$C$138,M568='Menu Data'!$C$158,M568='Menu Data'!$C$160),2,IF(AE575=1,3,0)))))","v":0},{"$f":"IF($M$568=\"\",0,IF(AND($AE$55=1,$M$568='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE568=0,1,IF(M568<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE568=1,M568='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE569","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE569","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE569","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE569","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE569","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ575","v":0},null,null,null,null,{"$f":"IF(AE568=0,0,(IF(M568<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$624=1,OR($M$624='Menu Data'!$C$160,$M$624='Menu Data'!$C$161)))),0,1)))))","v":0}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$564=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q617=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T617=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W617=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z617=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$617=0,FALSE,$AF$617)","v":false},{"$f":"IF($AE$617=0,FALSE,$AG$617)","v":false},{"$f":"IF($AE$617=0,FALSE,$AH$617)","v":false},{"$f":"IF($AE$617=0,FALSE,$AI$617)","v":false},{"$f":"IF(AE617=0,1,IF(AND($AJ$617:$AM$619=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ617=TRUE)*OR('Amendment Tool'!$M568='Menu Data'!$C$83,'Amendment Tool'!$M568='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK617=TRUE)*OR('Amendment Tool'!$M568='Menu Data'!$C$83,'Amendment Tool'!$M568='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL617=TRUE)*OR('Amendment Tool'!$M568='Menu Data'!$C$83,'Amendment Tool'!$M568='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM617=TRUE)*OR('Amendment Tool'!$M568='Menu Data'!$C$83,'Amendment Tool'!$M568='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$617=0,0,IF(AND($AE$617=1,OR($AJ$617=TRUE,$AK$617=TRUE,$AL$617=TRUE,$AM$617=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ617=FALSE),AND($AG$82=TRUE,AK617=FALSE),AND($AH$82=TRUE,AL617=FALSE),AND($AI$82=TRUE,AM617=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF618=2,AG618=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$564=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q619=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T619=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W619=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z619=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$619=0,FALSE,$AF$619)","v":false},{"$f":"IF($AE$619=0,FALSE,$AG$619)","v":false},{"$f":"IF($AE$619=0,FALSE,$AH$619)","v":false},{"$f":"IF($AE$619=0,FALSE,$AI$619)","v":false},{"$f":"IF(AE619=0,1,IF(AND($AJ$617:$AM$619=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ619=TRUE)*OR('Amendment Tool'!$M616='Menu Data'!$C$83,'Amendment Tool'!$M616='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK619=TRUE)*OR('Amendment Tool'!$M616='Menu Data'!$C$83,'Amendment Tool'!$M616='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL619=TRUE)*OR('Amendment Tool'!$M616='Menu Data'!$C$83,'Amendment Tool'!$M616='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM619=TRUE)*OR('Amendment Tool'!$M616='Menu Data'!$C$83,'Amendment Tool'!$M616='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AH620","v":"Add another change"},null,null,null,null,null,null,null,{"$f":"$AE$566","v":0},false,{"$f":"IF($AE$620=0,FALSE,$AF$620)","v":false},{"$f":"IF(AG620=TRUE,\"Remove all changes below\",\"Add another change\")","v":"Add another change"}]
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[null,null,"Change 10",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$620=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$622","v":0},null,{"$f":"IF($M$623=\"\",1,IF(COUNTIF(Area_18,$M$623)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE623=0,1,IF(M623<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$622","v":0},{"$f":"IF($M$624=\"\",1,(IF($M$623=\"\",1,IF($AE$624=0,1,IF(COUNTIF(INDIRECT($AG$624),$M$624),1,0)))))","v":1},{"$f":"VLOOKUP($M623,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,{"$f":"IF($M$624=\"\",0,IF(OR($M$624=$M$120,$M$624=$M$176,$M$624=$M$232,$M$624=$M$288,$M$624=$M$344,$M$624=$M$400,$M$624=$M$456,$M$624=$M$512,$M$624=$M$568),1,0))","v":0},{"$f":"IF(AE624=0,0,(IF(OR(M624='Menu Data'!$C$75,M624='Menu Data'!$C$77,M624='Menu Data'!$C$131,M624='Menu Data'!$C$137,M624='Menu Data'!$C$139,M624='Menu Data'!$C$159,M624='Menu Data'!$C$161),1,IF(OR(M624='Menu Data'!$C$74,M624='Menu Data'!$C$76,M624='Menu Data'!$C$132,M624='Menu Data'!$C$136,M624='Menu Data'!$C$138,M624='Menu Data'!$C$158,M624='Menu Data'!$C$160),2,IF(AE631=1,3,0)))))","v":0},{"$f":"IF($M$624=\"\",0,IF(AND($AE$55=1,$M$624='Menu Data'!$C$87),1,0))","v":0},null,null,{"$f":"IF(AE624=0,1,IF(M624<>\"\",1,0))","v":1}]
[null,null,"Date of temporary halt (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AE624=1,M624='Menu Data'!$C$122),1,0)","v":0}]
[null,null,"Recruitment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE625","v":0},2]
[null,null,"Treatment has been stopped:",null,null,null,null,null,null,null,null,null,"Yes",null,null,null,null,null,null,null,"No",null,null,null,null,null,null,null,null,null,{"$f":"AE625","v":0},2]
[null,null,"Number of participants still receiving treatment in the UK at the time of the temporary halt:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE625","v":0}]
[null,null,"In the further information free text below, briefly describe:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE625","v":0}]
[null,null,"- Justification for a temporary halt of the trial\n- The proposed management of participants receiving treatment at the time of the halt\n- The consequences of the temporary halt for the evaluation of the results and for the overall risk benefit assessment of the investigational medicinal product\n- Details of any other trials in the UK that will also be affected by the temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE625","v":0}]
[null,null,"Where a substantial change is being made to the IB or SmPC (e.g. affecting the risk/benefit assessment), it would normally be expected that this would be accompanied by a significant change to study documents (e.g. information sheets) to notify participants about the updated risk/benefit assessment. Please enter a separate change in the amendment tool for a significant change to study documents or provide a justification in the free text below setting out why the study documents are not being updated:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AJ631","v":0},null,null,null,null,{"$f":"IF(AE624=0,0,(IF(M624<>'Menu Data'!$C$155,0,(IF((OR(AND($AE$120=1,OR($M$120='Menu Data'!$C$160,$M$120='Menu Data'!$C$161)),AND($AE$176=1,OR($M$176='Menu Data'!$C$160,$M$176='Menu Data'!$C$161)),AND($AE$232=1,OR($M$232='Menu Data'!$C$160,$M$232='Menu Data'!$C$161)),AND($AE$288=1,OR($M$288='Menu Data'!$C$160,$M$288='Menu Data'!$C$161)),AND($AE$344=1,OR($M$344='Menu Data'!$C$160,$M$344='Menu Data'!$C$161)),AND($AE$400=1,OR($M$400='Menu Data'!$C$160,$M$400='Menu Data'!$C$161)),AND($AE$456=1,OR($M$456='Menu Data'!$C$160,$M$456='Menu Data'!$C$161)),AND($AE$512=1,OR($M$512='Menu Data'!$C$160,$M$512='Menu Data'!$C$161)),AND($AE$568=1,OR($M$568='Menu Data'!$C$160,$M$568='Menu Data'!$C$161)))),0,1)))))","v":0}]
[null,null,{"$f":"AJ632","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$622","v":0},{"$f":"LEN($M$632)","v":0},{"$f":"COUNTIF(AW632:AW671,1)*$AI$632","v":0},{"$f":"AT671-AG632","v":3200},80,{"$f":"CONCATENATE(\"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers\",AK632)","v":"Further information: explain what the change is, why the change is being made and any possible impact on study participants/carers (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ624=1,\". In particular, please describe the additional resource arrangements that participating organisations will need to have in place to implement this change (free text - note that this field will adapt to the amount of text entered)*:\",IF(AJ624=2,\". In particular, please describe why this change can be implemented within the existing resource in place at the participating organisations (free text - note that this field will adapt to the amount of text entered)*\",IF(AJ624=3,\" (free text - note that this field will adapt to the amount of text entered)*:\",\" (free text - note that this field will adapt to the amount of text entered):\")))","v":" (free text - note that this field will adapt to the amount of text entered):"},{"$f":"IF(AJ624=2,\"In particular, please describe the additional resource arrangements that participating organisations will need to implement this change*\",\"\")","v":""},null,{"$f":"IF(OR(AE632=0,AJ624=0),1,IF(M632<>0,1,0))","v":1},null,null,null,null,1,{"$f":"AS632*$AI$632","v":80},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$632,1)),(FIND(CHAR(10),$M$632,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$632,1)),(FIND(CHAR(13),$M$632,1)),0)","v":0},{"$f":"IF(OR(AU632>0,AV632>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AW632:AW671,1),COUNTIF(AX632:AX671,1))","v":1}]
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[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Yes",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$76=1,$AF$76=1,$AG$620=TRUE),$AE$169,0)","v":0},{"$f":"IF($Q673=\"Yes\",TRUE,FALSE)","v":true},{"$f":"IF($T673=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W673=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z673=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$673=0,FALSE,$AF$673)","v":false},{"$f":"IF($AE$673=0,FALSE,$AG$673)","v":false},{"$f":"IF($AE$673=0,FALSE,$AH$673)","v":false},{"$f":"IF($AE$673=0,FALSE,$AI$673)","v":false},{"$f":"IF(AE673=0,1,IF(AND($AJ$673:$AM$675=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$81=FALSE,AJ673=TRUE)*OR('Amendment Tool'!$M624='Menu Data'!$C$83,'Amendment Tool'!$M624='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$81=FALSE,AK673=TRUE)*OR('Amendment Tool'!$M624='Menu Data'!$C$83,'Amendment Tool'!$M624='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$81=FALSE,AL673=TRUE)*OR('Amendment Tool'!$M624='Menu Data'!$C$83,'Amendment Tool'!$M624='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$81=FALSE,AM673=TRUE)*OR('Amendment Tool'!$M624='Menu Data'!$C$83,'Amendment Tool'!$M624='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,"All",null,null,null,null,null,"Some",null,null,null,null,null,null,null,{"$f":"IF($AE$673=0,0,IF(AND($AE$673=1,OR($AJ$673=TRUE,$AK$673=TRUE,$AL$673=TRUE,$AM$673=TRUE)),1,0))","v":0},1,{"$f":"IF(OR(AND($AF$82=TRUE,AJ673=FALSE),AND($AG$82=TRUE,AK673=FALSE),AND($AH$82=TRUE,AL673=FALSE),AND($AI$82=TRUE,AM673=FALSE)),2,1)","v":2},{"$f":"IF(OR(AF674=2,AG674=2),2,1)","v":2}]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,"No",null,null,"No",null,null,"No",null,null,"No",null,null,null,null,{"$f":"IF(AND($AE$78=1,$AF$78=1,$AG$620=TRUE),$AE$171,0)","v":0},{"$f":"IF($Q675=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($T675=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($W675=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($Z675=\"Yes\",TRUE,FALSE)","v":false},{"$f":"IF($AE$675=0,FALSE,$AF$675)","v":false},{"$f":"IF($AE$675=0,FALSE,$AG$675)","v":false},{"$f":"IF($AE$675=0,FALSE,$AH$675)","v":false},{"$f":"IF($AE$675=0,FALSE,$AI$675)","v":false},{"$f":"IF(AE675=0,1,IF(AND($AJ$673:$AM$675=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$87=FALSE,AJ675=TRUE)*OR('Amendment Tool'!$M672='Menu Data'!$C$83,'Amendment Tool'!$M672='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$87=FALSE,AK675=TRUE)*OR('Amendment Tool'!$M672='Menu Data'!$C$83,'Amendment Tool'!$M672='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$87=FALSE,AL675=TRUE)*OR('Amendment Tool'!$M672='Menu Data'!$C$83,'Amendment Tool'!$M672='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$87=FALSE,AM675=TRUE)*OR('Amendment Tool'!$M672='Menu Data'!$C$83,'Amendment Tool'!$M672='Menu Data'!$C$84),1,0)","v":0}]
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[null,"Amendment documents",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$108=1,$AF$677=1),1,0)","v":0},0,"Added a dependency here just to switch off the document list. Changing this cell to 1 would turn it back on, or amend the formula in the cell to the left to remove the dependency."]
[null,null,"How many documents are being submitted for this amendment?\n(number between 1 and 50):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$677","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$685","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$691","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$697","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$703","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$709","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,{"$f":"CONCATENATE(\"Document \",AG716)","v":"Document 7"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$715","v":0},null,{"$f":"AG710+1","v":7}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$715","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,{"$f":"CONCATENATE(\"Document \",AG722)","v":"Document 8"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$721","v":0},null,{"$f":"AG716+1","v":8}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$721","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$727","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$769","v":0}]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$769","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$775","v":0}]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG782,1,0)","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$781","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$787","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$793","v":0}]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG800,1,0)","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$799","v":0}]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG806,1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"Document \",AG806)","v":"Document 22"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$805","v":0},null,{"$f":"AG800+1","v":22}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$805","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG812,1,0)","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$811","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$811","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG818,1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"Document \",AG818)","v":"Document 24"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$817","v":0},null,{"$f":"AG812+1","v":24}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$817","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Version:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG824,1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"Document \",AG824)","v":"Document 25"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$823","v":0},null,{"$f":"AG818+1","v":25}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$823","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Version:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG830,1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"Document \",AG830)","v":"Document 26"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$829","v":0},null,{"$f":"AG824+1","v":26}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$829","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$877","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$883","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$889","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$895","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$901","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$907","v":0}]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$913","v":0}]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG920,1,0)","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$919","v":0}]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($Q$678>=AG926,1,0)","v":0}]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$925","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Document date (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,{"$f":"CONCATENATE(\"Document \",AG950)","v":"Document 46"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$949","v":0},null,{"$f":"AG944+1","v":46}]
[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$949","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$973","v":0}]
[null,null,"Title:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,"Section 3: Declaration(s) and lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Declaration by the Sponsor or authorised delegate",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null," •  I confirm that the Sponsor takes responsibility for the completed amendment tool\n •  I confirm that I have been formally authorised by the Sponsor to complete the amendment tool on their behalf",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$108","v":1}]
[null,null,"Applicant identification:",null,null,null,null,null,null,null,"Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$108=1,$AE$60=1,$AF$60=1,$J$1024='Menu Data'!$A$31),1,0)","v":0},1]
[null,null,null,null,null,null,null,null,null,null,"Legal representative of the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,null,null,null,null,null,null,null,null,"Person or organisation authorised by the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Name [first name and surname]*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,1,null,null,null,null,null,null,null,{"$f":"IF(K988<>\"\",1,0)","v":0}]
[null,null,"Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Purchase Order (PO) number for MHRA invoicing:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$984","v":0}]
[null,null,"Email address*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF(K993<>\"\",1,0)","v":0}]
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[null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Please note: This button will only become available when all mandatory (*) fields have been completed. When the button is available, clicking it will generate a locked PDF copy of the completed amendment tool which must be included in the amendment submission. Please ensure that the amendment tool is completed correctly before locking it for submission.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(AN6:AN993,0),0,1)","v":0}]
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[null,null,"After locking the tool, proceed to submit the amendment online. The \"Submission Guidance\" tab provides further information about the next steps for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$108=1,$AE$1000=0),1,0)","v":1}]
[null,null,"After locking the tool, amendments to trials processed under the combined review service should be made using the new part of IRAS. Further information can be found on the \"Submission Guidance\" tab.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$108=1,$AE$62=1,$AF$62=1),1,0)","v":0}]
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[null,"Section 4: Review bodies for the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Please note: This section is for information only. Details in this section will complete automatically based on the options selected in Sections 1 and 2.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,"Review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,"UK wide:",null,null,null,null,null,"England and Wales:",null,null,null,"Scotland:",null,null,null,"Northern Ireland:",null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,{"$f":"IF($AF$55=1,\"REC\",\"MoDREC\")","v":"REC"},"Competent Authority\nMHRA - Medicines","Competent Authority\nMHRA - Devices","ARSAC","Radiation Assurance","UKSW Governance","REC (MCA)","CAG","HMPPS","HRA and HCRW Approval","REC (AWIA)","PBPP","SPS (RAEC)",{"$f":"IF(AND($AE$85=1,$AF$85=1),\"NHS organisation\",\"National coordinating function\")","v":"National coordinating function"},"HSC REC","HSC Data Guardians","Prisons",{"$f":"IF(AND($AG$86=1,$AF$86=1),\"NHS organisation\",\"National coordinating function\")","v":"National coordinating function"},null,null,null,null,1]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Category:",null,null,null,1,null,null,null,null,null,null,null,null,"Type:","Annex 2 type:","Annex 2 reason:","CWoW:"]
[null,null,"Change 1:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$33,Arrays!$K$18='Menu Data'!$A$33,Arrays!$K$28='Menu Data'!$A$33,Arrays!$K$38='Menu Data'!$A$33,Arrays!$K$48='Menu Data'!$A$33,Arrays!$K$58='Menu Data'!$A$33,Arrays!$K$68='Menu Data'!$A$33,Arrays!$K$78='Menu Data'!$A$33,Arrays!$K$88='Menu Data'!$A$33,Arrays!$K$98='Menu Data'!$A$33),\"\",Arrays!$K$8)","v":""},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$33,Arrays!$L$18='Menu Data'!$A$33,Arrays!$L$28='Menu Data'!$A$33,Arrays!$L$38='Menu Data'!$A$33,Arrays!$L$48='Menu Data'!$A$33,Arrays!$L$58='Menu Data'!$A$33,Arrays!$L$68='Menu Data'!$A$33,Arrays!$L$78='Menu Data'!$A$33,Arrays!$L$88='Menu Data'!$A$33,Arrays!$L$98='Menu Data'!$A$33),\"\",Arrays!$L$8)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$33,Arrays!$M$18='Menu Data'!$A$33,Arrays!$M$28='Menu Data'!$A$33,Arrays!$M$38='Menu Data'!$A$33,Arrays!$M$48='Menu Data'!$A$33,Arrays!$M$58='Menu Data'!$A$33,Arrays!$M$68='Menu Data'!$A$33,Arrays!$M$78='Menu 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[null,null,"Change 2:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$33,Arrays!$K$18='Menu Data'!$A$33,Arrays!$K$28='Menu Data'!$A$33,Arrays!$K$38='Menu Data'!$A$33,Arrays!$K$48='Menu Data'!$A$33,Arrays!$K$58='Menu Data'!$A$33,Arrays!$K$68='Menu Data'!$A$33,Arrays!$K$78='Menu Data'!$A$33,Arrays!$K$88='Menu Data'!$A$33,Arrays!$K$98='Menu Data'!$A$33),\"\",Arrays!$K$18)","v":""},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$33,Arrays!$L$18='Menu Data'!$A$33,Arrays!$L$28='Menu Data'!$A$33,Arrays!$L$38='Menu Data'!$A$33,Arrays!$L$48='Menu Data'!$A$33,Arrays!$L$58='Menu Data'!$A$33,Arrays!$L$68='Menu Data'!$A$33,Arrays!$L$78='Menu Data'!$A$33,Arrays!$L$88='Menu Data'!$A$33,Arrays!$L$98='Menu Data'!$A$33),\"\",Arrays!$L$18)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$33,Arrays!$M$18='Menu Data'!$A$33,Arrays!$M$28='Menu Data'!$A$33,Arrays!$M$38='Menu Data'!$A$33,Arrays!$M$48='Menu Data'!$A$33,Arrays!$M$58='Menu Data'!$A$33,Arrays!$M$68='Menu Data'!$A$33,Arrays!$M$78='Menu 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[null,null,"Change 3:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$33,Arrays!$K$18='Menu Data'!$A$33,Arrays!$K$28='Menu Data'!$A$33,Arrays!$K$38='Menu Data'!$A$33,Arrays!$K$48='Menu Data'!$A$33,Arrays!$K$58='Menu Data'!$A$33,Arrays!$K$68='Menu Data'!$A$33,Arrays!$K$78='Menu Data'!$A$33,Arrays!$K$88='Menu Data'!$A$33,Arrays!$K$98='Menu Data'!$A$33),\"\",Arrays!$K$28)","v":""},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$33,Arrays!$L$18='Menu Data'!$A$33,Arrays!$L$28='Menu Data'!$A$33,Arrays!$L$38='Menu Data'!$A$33,Arrays!$L$48='Menu Data'!$A$33,Arrays!$L$58='Menu Data'!$A$33,Arrays!$L$68='Menu Data'!$A$33,Arrays!$L$78='Menu Data'!$A$33,Arrays!$L$88='Menu Data'!$A$33,Arrays!$L$98='Menu Data'!$A$33),\"\",Arrays!$L$28)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$33,Arrays!$M$18='Menu Data'!$A$33,Arrays!$M$28='Menu Data'!$A$33,Arrays!$M$38='Menu Data'!$A$33,Arrays!$M$48='Menu Data'!$A$33,Arrays!$M$58='Menu Data'!$A$33,Arrays!$M$68='Menu Data'!$A$33,Arrays!$M$78='Menu 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[null,null,"Change 5:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$33,Arrays!$K$18='Menu Data'!$A$33,Arrays!$K$28='Menu Data'!$A$33,Arrays!$K$38='Menu Data'!$A$33,Arrays!$K$48='Menu Data'!$A$33,Arrays!$K$58='Menu Data'!$A$33,Arrays!$K$68='Menu Data'!$A$33,Arrays!$K$78='Menu Data'!$A$33,Arrays!$K$88='Menu Data'!$A$33,Arrays!$K$98='Menu Data'!$A$33),\"\",Arrays!$K$48)","v":""},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$33,Arrays!$L$18='Menu Data'!$A$33,Arrays!$L$28='Menu Data'!$A$33,Arrays!$L$38='Menu Data'!$A$33,Arrays!$L$48='Menu Data'!$A$33,Arrays!$L$58='Menu Data'!$A$33,Arrays!$L$68='Menu Data'!$A$33,Arrays!$L$78='Menu Data'!$A$33,Arrays!$L$88='Menu Data'!$A$33,Arrays!$L$98='Menu Data'!$A$33),\"\",Arrays!$L$48)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$33,Arrays!$M$18='Menu Data'!$A$33,Arrays!$M$28='Menu Data'!$A$33,Arrays!$M$38='Menu Data'!$A$33,Arrays!$M$48='Menu Data'!$A$33,Arrays!$M$58='Menu Data'!$A$33,Arrays!$M$68='Menu Data'!$A$33,Arrays!$M$78='Menu 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[null,null,"Change 7:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$33,Arrays!$K$18='Menu Data'!$A$33,Arrays!$K$28='Menu Data'!$A$33,Arrays!$K$38='Menu Data'!$A$33,Arrays!$K$48='Menu Data'!$A$33,Arrays!$K$58='Menu Data'!$A$33,Arrays!$K$68='Menu Data'!$A$33,Arrays!$K$78='Menu Data'!$A$33,Arrays!$K$88='Menu Data'!$A$33,Arrays!$K$98='Menu Data'!$A$33),\"\",Arrays!$K$68)","v":""},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$33,Arrays!$L$18='Menu Data'!$A$33,Arrays!$L$28='Menu Data'!$A$33,Arrays!$L$38='Menu Data'!$A$33,Arrays!$L$48='Menu Data'!$A$33,Arrays!$L$58='Menu Data'!$A$33,Arrays!$L$68='Menu Data'!$A$33,Arrays!$L$78='Menu Data'!$A$33,Arrays!$L$88='Menu Data'!$A$33,Arrays!$L$98='Menu Data'!$A$33),\"\",Arrays!$L$68)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$33,Arrays!$M$18='Menu Data'!$A$33,Arrays!$M$28='Menu Data'!$A$33,Arrays!$M$38='Menu Data'!$A$33,Arrays!$M$48='Menu Data'!$A$33,Arrays!$M$58='Menu Data'!$A$33,Arrays!$M$68='Menu Data'!$A$33,Arrays!$M$78='Menu 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Data'!$A$33,Arrays!$V$18='Menu Data'!$A$33,Arrays!$V$28='Menu Data'!$A$33,Arrays!$V$38='Menu Data'!$A$33,Arrays!$V$48='Menu Data'!$A$33,Arrays!$V$58='Menu Data'!$A$33,Arrays!$V$68='Menu Data'!$A$33,Arrays!$V$78='Menu Data'!$A$33,Arrays!$V$88='Menu Data'!$A$33,Arrays!$V$98='Menu Data'!$A$33),\"\",Arrays!$V$98)","v":""},{"$f":"IF(AND(Arrays!$W$8='Menu Data'!$A$33,Arrays!$W$18='Menu Data'!$A$33,Arrays!$W$28='Menu Data'!$A$33,Arrays!$W$38='Menu Data'!$A$33,Arrays!$W$48='Menu Data'!$A$33,Arrays!$W$58='Menu Data'!$A$33,Arrays!$W$68='Menu Data'!$A$33,Arrays!$W$78='Menu Data'!$A$33,Arrays!$W$88='Menu Data'!$A$33,Arrays!$W$98='Menu Data'!$A$33),\"\",Arrays!$W$98)","v":""},{"$f":"IF(AND(Arrays!$X$8='Menu Data'!$A$33,Arrays!$X$18='Menu Data'!$A$33,Arrays!$X$28='Menu Data'!$A$33,Arrays!$X$38='Menu Data'!$A$33,Arrays!$X$48='Menu Data'!$A$33,Arrays!$X$58='Menu Data'!$A$33,Arrays!$X$68='Menu Data'!$A$33,Arrays!$X$78='Menu Data'!$A$33,Arrays!$X$88='Menu Data'!$A$33,Arrays!$X$98='Menu Data'!$A$33),\"\",Arrays!$X$98)","v":""},{"$f":"IF(AND(Arrays!$Y$8='Menu Data'!$A$33,Arrays!$Y$18='Menu Data'!$A$33,Arrays!$Y$28='Menu Data'!$A$33,Arrays!$Y$38='Menu Data'!$A$33,Arrays!$Y$48='Menu Data'!$A$33,Arrays!$Y$58='Menu Data'!$A$33,Arrays!$Y$68='Menu Data'!$A$33,Arrays!$Y$78='Menu Data'!$A$33,Arrays!$Y$88='Menu Data'!$A$33,Arrays!$Y$98='Menu Data'!$A$33),\"\",Arrays!$Y$98)","v":""},{"$f":"IF(AND(Arrays!$Z$8='Menu Data'!$A$33,Arrays!$Z$18='Menu Data'!$A$33,Arrays!$Z$28='Menu Data'!$A$33,Arrays!$Z$38='Menu Data'!$A$33,Arrays!$Z$48='Menu Data'!$A$33,Arrays!$Z$58='Menu Data'!$A$33,Arrays!$Z$68='Menu Data'!$A$33,Arrays!$Z$78='Menu Data'!$A$33,Arrays!$Z$88='Menu Data'!$A$33,Arrays!$Z$98='Menu Data'!$A$33),\"\",Arrays!$Z$98)","v":""},{"$f":"IF(AND(Arrays!$AA$8='Menu Data'!$A$33,Arrays!$AA$18='Menu Data'!$A$33,Arrays!$AA$28='Menu Data'!$A$33,Arrays!$AA$38='Menu Data'!$A$33,Arrays!$AA$48='Menu Data'!$A$33,Arrays!$AA$58='Menu Data'!$A$33,Arrays!$AA$68='Menu Data'!$A$33,Arrays!$AA$78='Menu Data'!$A$33,Arrays!$AA$88='Menu Data'!$A$33,Arrays!$AA$98='Menu Data'!$A$33),\"\",Arrays!$AA$98)","v":""},{"$f":"IF(AND(Arrays!$AB$8='Menu Data'!$A$33,Arrays!$AB$18='Menu Data'!$A$33,Arrays!$AB$28='Menu Data'!$A$33,Arrays!$AB$38='Menu Data'!$A$33,Arrays!$AB$48='Menu Data'!$A$33,Arrays!$AB$58='Menu Data'!$A$33,Arrays!$AB$68='Menu Data'!$A$33,Arrays!$AB$78='Menu Data'!$A$33,Arrays!$AB$88='Menu Data'!$A$33,Arrays!$AB$98='Menu Data'!$A$33),\"\",Arrays!$AB$98)","v":""},{"$f":"IF(Arrays!$AC$98='Menu Data'!$A$45,\"\",Arrays!$AC$98)","v":""},null,null,null,{"$f":"IF($AE$108=0,0,IF($AG$620=TRUE,1,0))","v":0},null,null,null,null,null,null,null,null,{"$f":"Arrays!J98","v":""},{"$f":"Arrays!AD98","v":""},{"$f":"Arrays!AE98","v":""},{"$f":"Arrays!AF98","v":""}]
[null,null,"Overall reviews for the amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$108","v":1},null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AQ$1013:$AQ$1022=\"\",\"\",IF(OR($AQ$1013:$AQ$1022='Menu Data'!$A$88),\"Yes\",\"No\"))","v":""}]
[null,null,"Full review:",null,null,null,null,null,{"$f":"Arrays!G2","v":""},{"$f":"Arrays!G3","v":""},{"$f":"Arrays!G4","v":""},{"$f":"Arrays!G5","v":""},{"$f":"Arrays!G6","v":""},{"$f":"Arrays!G7","v":""},{"$f":"Arrays!G8","v":""},{"$f":"Arrays!G9","v":""},{"$f":"Arrays!G10","v":""},{"$f":"Arrays!G11","v":""},{"$f":"Arrays!G12","v":""},{"$f":"Arrays!G13","v":""},{"$f":"Arrays!G14","v":""},{"$f":"Arrays!G15","v":""},{"$f":"Arrays!G16","v":""},{"$f":"Arrays!G17","v":""},{"$f":"Arrays!G18","v":""},{"$f":"Arrays!G19","v":""},null,null,null,null,{"$f":"$AE$108","v":1},null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AQ$1013:$AQ$1022=\"\",\"\",IF(OR($AQ$1013:$AQ$1022='Menu Data'!$A$89),\"Yes\",\"No\"))","v":""}]
[null,null,"Notification only:",null,null,null,null,null,{"$f":"Arrays!H2","v":""},{"$f":"Arrays!H3","v":""},{"$f":"Arrays!H4","v":""},{"$f":"Arrays!H5","v":""},{"$f":"Arrays!H6","v":""},{"$f":"Arrays!H7","v":""},{"$f":"Arrays!H8","v":""},{"$f":"Arrays!H9","v":""},{"$f":"Arrays!H10","v":""},{"$f":"Arrays!H11","v":""},{"$f":"Arrays!H12","v":""},{"$f":"Arrays!H13","v":""},{"$f":"Arrays!H14","v":""},{"$f":"Arrays!H15","v":""},{"$f":"Arrays!H16","v":""},{"$f":"Arrays!H17","v":""},{"$f":"Arrays!H18","v":""},{"$f":"Arrays!H19","v":""},null,null,null,null,{"$f":"$AE$108","v":1}]
[null,null,"Overall amendment type:",null,null,null,null,null,{"$f":"Arrays!$E$53","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$108","v":1}]
[null,null,"Overall Category:",null,null,null,null,null,{"$f":"Arrays!$E$23","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,$AJ$168)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF($AE$1029=1,1,0))","v":0}]
[null,null,"Please note: This amendment should not be processed via online submission. Please contact the REC directly to submit this amendment. See the \"Submission Guidance\" tab for further information.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AF$1029=1,$AG$1029=1),1,0))","v":0},{"$f":"IF(AND($AE$57=1,$AF$57=1),1,0)","v":0},{"$f":"IF($AI$100=1,1,IF(OR($M$120='Menu Data'!$C$72,$M$176='Menu Data'!$C$72,$M$232='Menu Data'!$C$72,$M$288='Menu Data'!$C$72,$M$344='Menu Data'!$C$72,$M$400='Menu Data'!$C$72,$M$456='Menu Data'!$C$72,$M$512='Menu Data'!$C$72,$M$568='Menu Data'!$C$72,$M$624='Menu Data'!$C$72),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF($AE$1031=1,1,0))","v":0}]
[null,null,"Please note: Whilst this is a non-notifiable amendment, meaning that there is no need to make an online submisssion for review, it may still need to be shared with participating organisations. See the \"Submission Guidance\" tab for further information.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($I$1026='Menu Data'!$A$28,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$1029=1,1,IF($AE$108=0,0,IF(OR($AE$1034=1,$AE$1038=1),1,0)))","v":0}]
[null,null,"For national coordinating function office use:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AE$1034=1,$AE$1038=1),1,0))","v":0}]
[null,null,"New nation(s):",null,null,null,null,null,{"$f":"IF(AND(AF1034=\"\",AG1034=\"\",AH1034=\"\",AI1034=\"\"),\"\",AM1034)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AF$1034<>\"\",$AG$1034<>\"\",$AH$1034<>\"\",$AI$1034<>\"\"),1,0))","v":0},{"$f":"IF(AND($AF$81=FALSE,$AF$82=TRUE),\"England\",\"\")","v":""},{"$f":"IF(AND($AG$81=FALSE,$AG$82=TRUE),\"Wales\",\"\")","v":""},{"$f":"IF(AND($AH$81=FALSE,$AH$82=TRUE),\"Scotland\",\"\")","v":""},{"$f":"IF(AND($AI$81=FALSE,$AI$82=TRUE),\"Northern Ireland\",\"\")","v":""},{"$f":"IF(AND($AF$1034<>\"\")*OR($AG$1034<>\"\",$AH$1034<>\"\",$AI$1034<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AG$1034<>\"\")*OR($AH$1034<>\"\",$AI$1034<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AH$1034<>\"\",$AI$1034<>\"\"),\"; \",\"\")","v":""},{"$f":"CONCATENATE(\"This amendment adds new participating nation(s) for the first time: \",$AF$1034,$AJ$1034,$AG$1034,$AK$1034,$AH$1034,$AL$1034,$AI$1034,\". Ensure that HARP is updated.\")","v":"This amendment adds new participating nation(s) for the first time: . Ensure that HARP is updated."}]
[null,null,"Northern Ireland IVD:",null,null,null,null,null,"This amendment may involve an IVD for Northern Ireland and may require a submission or notification to MHRA Devices in order to comply with Northern Ireland regulation only. Northern Ireland Coordinating function - Contact research.approvals@hscni.net to establish whether advice has already been provided.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AJ$66=1,$AJ$67=1),1,0)","v":0}]
[null,null,"NIHR CRN portfolio notification in England:",null,null,null,null,null,"This amendment adds England as a participating nation for the first time, and the study is intended for inclusion on the NIHR portfolio in England. Ensure that the CRN is notified.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$83=1,$AF$83=1),1,0)","v":0}]
[null,null,"Adults lacking capacity in new nation(s):",null,null,null,null,null,{"$f":"IF(AND(AF1037=\"\",AG1037=\"\",AH1037=\"\",AI1037=\"\"),\"\",AM1037)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AI$99=1,1,IF(COUNTIF(Arrays!$AO$99:$AR$99,1),1,0))","v":0},{"$f":"IF(OR($AJ$99=1,Arrays!$AO$99=1),\"England\",\"\")","v":""},{"$f":"IF(OR($AK$99=1,Arrays!$AP$99=1),\"Wales\",\"\")","v":""},{"$f":"IF(OR(AL99=1,Arrays!AQ99=1),\"Scotland\",\"\")","v":""},{"$f":"IF(OR($AM$99=1,Arrays!$AR$99=1),\"Northern Ireland\",\"\")","v":""},{"$f":"IF(AND($AF$1037<>\"\")*OR($AG$1037<>\"\",$AH$1037<>\"\",$AI$1037<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AG$1037<>\"\")*OR($AH$1037<>\"\",$AI$1037<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AH$1037<>\"\",$AI$1037<>\"\"),\"; \",\"\")","v":""},{"$f":"CONCATENATE(\"This amendment may include adults who lose/lack capacity for the first time in: \",AF1037,AJ1037,AG1037,AK1037,AH1037,AL1037,AI1037,\". The original REC review was undertaken in: \",'Submission Guidance'!AG42,\". Consider whether a new REC review is required to cover the new nation(s) being added and advise the applicant.\")","v":"This amendment may include adults who lose/lack capacity for the first time in: . The original REC review was undertaken in: England. Consider whether a new REC review is required to cover the new nation(s) being added and advise the applicant."}]
[null,null,"Update HARP:",null,null,null,null,null,"This amendment may involve an update to contact details, project end date, or other project details. Ensure that HARP is updated with the current details. If this is the only change, no further study-wide review is required.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(Arrays!$AS$99=1,1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AE$1034=1,$AE$1038=1,$AE$1037=1,$AE$1040=1,$AE$1045=1),1,0))","v":0}]
[null,null,"For MHRA office use:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR($AE$1041=1,$AE$1042=1,$AE$1043=1),1,0))","v":0}]
[null,null,"This amendment concerns urgent safety measures already implemented",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$52),1,0))","v":0}]
[null,null,"This amendment notifies a temporary halt of the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$53),1,0))","v":0}]
[null,null,"This amendment requests a restart of the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$54),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,$AE$1040)","v":0}]
[null,null,"This amendment relates to:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF($AE$108=0,0,IF(AND($AE$109=1,$AF$109=4)*OR($I$1026='Menu Data'!$A$23,$I$1026='Menu Data'!$A$24,$I$1026='Menu Data'!$A$25),1,0))","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case Part1/2 needs to be added back in future"]
[null,null,"Part 1:",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AQ$1023","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AF$1045","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case Part1/2 needs to be added back in future"]
[null,null,"Part 2:",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AQ$1024","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AF$1045","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case Part1/2 needs to be added back in future"]
[null,null,"Notification for authorisation to the competent authority (MHRA - Medicines):",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($J$1024=\"\",\"\",IF($J$1024='Menu Data'!$A$31,\"Yes\",\"No\"))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AF$1045","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case CA/REC needs to be added back in future"]
[null,null,"Notification for an opinion to the ethics committee (REC):",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($I$1024=\"\",\"\",IF($I$1024='Menu Data'!$A$31,\"Yes\",\"No\"))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AF$1045","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case CA/REC needs to be added back in future"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AF$1049=1,$AF$1051=1),1,0)","v":0}]
[null,null,"Please note: As this is a non-substantial amendment to a CTIMP under the CTIMP combined review service (formerly known as the Combined Ways of Working (CWoW) pilot), this amendment should not be processed via online submission. Please see the \"Submission Guidance\" tab for further information.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF($AE$108=0,0,IF(AND($AE$109=1,$AF$109=4)*OR($I$1026='Menu Data'!$A$26,$I$1026='Menu Data'!$A$27),1,0))","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in case a CWoW prompt needs to be added back in future"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AF$1051","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$108=0,0,IF(AND($AE$1028=0,$AE$1032=0,$AE$1039=0,$AE$1050=0,$AE$1052=0),1,0))","v":1}]
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[null,"Please note: The information displayed on this page will update based on the selections made in the Amendment Tool so that the submission guidance is tailored to the amendment being made.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
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[null,"Instructions for submitting the amendment to REC",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$8=1,0,$AF$6)","v":0},{"$f":"IF(OR('Amendment Tool'!AF53=1,'Amendment Tool'!AF54=1),1,0)","v":1}]
[null,"Instructions for submitting the amendment for NHS/HSC review",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$8=1,0,$AF$7)","v":0},{"$f":"IF(OR('Amendment Tool'!$AF$76=1,'Amendment Tool'!$AF$77=1),1,0)","v":1}]
[null,"Instructions for submitting the amendment to REC and for NHS/HSC review",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$6=1,$AF$7=1),1,0)","v":1}]
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[null,null,"Please enter the full details about the amendment in the Amendment Tool before checking here for the submission guidance.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$12=1,$AE$13=1,$AE$14=1,$AE$15=1,$AE$16=1),0,IF(Arrays!$J$8=\"\",1,0))","v":1}]
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[null,null,"The answers in the Amendment Tool indicate that REC and NHS/HSC review are being sought for the first time. Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$101=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that MoDREC review is being sought for the first time. Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing modrec@mail.dstl.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$102=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this is an amendment to a research tissue bank. This tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$103=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this is an amendment to a research database. This tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$104=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that REC and NHS/HSC review are not applicable for this study, so there is no need to submit an amendment for these reviews.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$12=1,$AE$13=1,$AE$14=1,$AE$15=1),0,IF(AND('Amendment Tool'!$AF$50=1)*OR('Amendment Tool'!$AF$53=1,'Amendment Tool'!$AF$76=1,'Amendment Tool'!$AJ$66=1,'Amendment Tool'!$AJ$67=1),0,1))","v":0}]
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[null,null,"Your amendment is classed as \"non-notifiable\", meaning there is no need to make an online amendment submission for review.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$58,1,0)","v":0}]
[null,null,"Your amendment is classed as \"substantial\" and REC and/or NHS/HSC review is required.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$E$53=Arrays!$A$53,Arrays!$E$53=Arrays!$A$55),1,0)","v":0}]
[null,null,"Your amendment is classed as \"substantial for information\", meaning that it is a substantial amendment for the competent authority (MHRA - medicines), however, IRAS will automatically share the amendment for information only for REC and/or NHS/HSC review.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$54,1,0)","v":0}]
[null,null,"Your amendment is classed as \"non-substantial\", meaning NHS/HSC review is required.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$56,1,0)","v":0}]
[null,null,"Your amendment is classed as \"non-substantial, no study-wide review required\". These amendments should be submitted for information only but NHS/HSC review is not required. Please see the ‘Notifying participating organisations’ section below for details on how this amendment should be implemented at participating organisations.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$57,1,0)","v":0}]
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[null,null,"Once you have completed the Amendment Tool you should follow this link to online amendment submission. Please ensure all supporting documentation related to this amendment is also uploaded as part of your submission (this should include a locked PDF copy of the completed Amendment Tool).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$28=1,$AE$29=1),0,IF(OR($AE$19=1,$AE$20=1,$AE$21=1,$AE$22=1),1,0))","v":0}]
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[null,null,"If you are unfamiliar with making amendments, or require further guidance on the amendment process, please follow this link to our help pages.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$24","v":0}]
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[null,null,"Your amendment is a substantial amendment to a clinical trial of an investigational medicinal product (CTIMP) managed under the CTIMP combined review (formerly known as the combined ways of working (CWoW) pilot): Please submit this amendment via the process outlined in the guidance here, including a copy of the locked Amendment Tool. There is no need to submit to the REC separately.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1)*OR(Arrays!$G$2='Menu Data'!$A$31,Arrays!$G$3='Menu Data'!$A$31),1,0))","v":0}]
[null,null,"Your amendment is a non-substantial amendment to a clinical trial of an investigational medicinal product (CTIMP) managed under the CTIMP combined review (formerly known as the combined ways of working (CWoW) pilot): Please submit this amendment via the process outlined in the guidance here. This amendment should not be submitted via the online submission process.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1,Arrays!$G$2<>'Menu Data'!$A$31,Arrays!$G$3<>'Menu Data'!$A$31)*OR(Arrays!$H$2='Menu Data'!$A$31,Arrays!$H$3='Menu Data'!$A$31),1,0))","v":0}]
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[null,"REC review of amendments relating to adults who lose/lack capacity",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$33=1,$AE$37=1),1,0)","v":0}]
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[null,null,"Amendments to a study that already includes adults who lose/lack capacity",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(Arrays!$AM$99=1)*OR(Arrays!$AK$99=1,Arrays!AL99=1,Arrays!$AN$99=1),1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"The answers in the Amendment Tool indicate\",\" that this amendment changes the existing arrangements for adults who lose/lack capacity in \",AK34,\" and Scotland.\")","v":"The answers in the Amendment Tool indicate that this amendment changes the existing arrangements for adults who lose/lack capacity in  and Scotland."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$33","v":0},{"$f":"IF(Arrays!$AK$99=1,\"England\",\"\")","v":""},{"$f":"IF(AND(AF34<>\"\",AH34<>\"\"),\", \",\"\")","v":""},{"$f":"IF(Arrays!$AL$99=1,\"Wales\",\"\")","v":""},{"$f":"IF(AND(AH34<>\"\",AJ34<>\"\"),\", \",\"\")","v":""},{"$f":"IF(Arrays!$AN$99=1,\"Northern Ireland\",\"\")","v":""},{"$f":"CONCATENATE($AF$34,$AG$34,$AH$34,$AI$34,$AJ$34)","v":""}]
[null,null,"Please note: this will be an amendment to two different studies, as this activity would have required separate REC reviews originally: one for England, Wales and Northern Ireland, and another for Scotland. Each application submitted to each REC in the UK will have its own IRAS project ID and REC reference numbers.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$33","v":0}]
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[null,null,"Inclusion of adults who lose/lack capacity for the first time",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(AE40:AE51,1),1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this amendment may include adults who lose/lack capacity in one or more nations for the first time. Due to differences in the REC review requirements across the UK for studies involving adults lacking capacity, this change may require a new and separate REC review to cover the new nation(s) being added:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$37","v":0}]
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[null,null,{"$f":"CONCATENATE($AK$40,\":\")","v":":"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AK$40<>\"\",1,0)","v":0},{"$f":"IF(OR(Arrays!$AO$99=1,'Amendment Tool'!$AJ$99=1),\"England\",\"\")","v":""},{"$f":"IF(AF40=\"\",\"\",IF(AND(AF40<>\"\",AH40<>\"\",AJ40<>\"\"),\", \",IF(AND(AF40<>\"\")*OR(AH40<>\"\",AJ40<>\"\"),\" and \",\"\")))","v":""},{"$f":"IF(OR(Arrays!$AP$99=1,'Amendment Tool'!$AK$99=1),\"Wales\",\"\")","v":""},{"$f":"IF(AND(AF40=\"\",AH40=\"\"),\"\",IF(AND(AH40<>\"\",AJ40<>\"\"),\" and \",\"\"))","v":""},{"$f":"IF(OR(Arrays!AR99=1,'Amendment Tool'!$AM$99=1),\"Northern Ireland\",\"\")","v":""},{"$f":"CONCATENATE($AF$40,$AG$40,$AH$40,$AI$40,$AJ$40)","v":""}]
[null,null,{"$f":"CONCATENATE(\"The answers in the Amendment Tool indicate\",\" that this amendment includes adults who lose/lack capacity in \",AK40,\" for the first time. To undertake this activity, the study must have REC review by a flagged REC in England, Wales or Northern Ireland.\")","v":"The answers in the Amendment Tool indicate that this amendment includes adults who lose/lack capacity in  for the first time. To undertake this activity, the study must have REC review by a flagged REC in England, Wales or Northern Ireland."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$40","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$82=1,'Amendment Tool'!$AO$88=1),1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"The original REC review for this study was undertaken in \",AG42,\", so it may be possible to extend the existing REC opinion to this new activity.\")","v":"The original REC review for this study was undertaken in England, so it may be possible to extend the existing REC opinion to this new activity."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$40=1,$AF$42=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59<>3,1,0)","v":1},{"$f":"IF('Amendment Tool'!$AF$59=1,\"England\",IF('Amendment Tool'!$AF$59=2,\"Wales\",IF('Amendment Tool'!$AF$59=3,\"Scotland\",IF('Amendment Tool'!$AF$59=4,\"Northern Ireland\",\"\"))))","v":"England"}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$42","v":0}]
[null,null,"The original REC review for this study was undertaken in Scotland, so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a flagged REC in England, Wales or Northern Ireland has been undertaken previously, a new application will be needed to cover this activity.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$40=1,$AF$44=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59=3,1,0)","v":0}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$44","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$40","v":0}]
[null,null,"Scotland:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$AQ$99=1,'Amendment Tool'!$AL$99=1),1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this amendment includes adults who lose/lack capacity in Scotland for the first time. To undertake this activity, the study must have REC review by Scotland A REC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$47","v":0}]
[null,null,"The original REC review for this study was undertaken in Scotland. If the study was reviewed by Scotland A REC, it may be possible to extend the existing REC opinion to this new activity. If not, then a new application to Scotland A REC will be needed.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$47=1,$AF$49=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59=3,1,0)","v":0}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$49","v":0}]
[null,null,{"$f":"CONCATENATE(\"The original REC review for this study was undertaken in \",AG42,\", so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a Scotland A REC has been undertaken previously\",\", a new application will be needed to cover this activity.\")","v":"The original REC review for this study was undertaken in England, so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a Scotland A REC has been undertaken previously, a new application will be needed to cover this activity."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$47=1,$AF$51=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59<>3,1,0)","v":1}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$51","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$47","v":0}]
[null,null,"Please note: This amendment is adding adults who lose/lack capacity to a project in one or more nations for the first time. This amendment should not be submitted via the online submission process. Instead please follow the instructions outlined above.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$37","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$37","v":0}]
[null,"REC review of modified amendments",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$57=1,'Amendment Tool'!$AF$57=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,null,"Please note: As this is a submission of a modified amendment, it should be submitted to the REC alongside all supporting documentation by email. Where applicable, the REC will share the amendment and Amendment Tool with the relevant national coordinating function for the lead nation.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,null,"Modified amendments must not be submitted using online submission.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,"Updates required to the original IRAS form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$67:$AE$79,1),1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this amendment will require an update to the information about the study on the original IRAS form:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$64","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$64","v":0}]
[null,"Ionising radiation information to be provided to the REC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(OR($AF$67=1,$AG$67=1),1,0))","v":0},{"$f":"IF(OR('Amendment Tool'!$M$119='Menu Data'!$A$14,'Amendment Tool'!$M$175='Menu Data'!$A$14,'Amendment Tool'!$M$231='Menu Data'!$A$14,'Amendment Tool'!$M$287='Menu Data'!$A$14,'Amendment Tool'!$M$343='Menu Data'!$A$14,'Amendment Tool'!$M$399='Menu Data'!$A$14,'Amendment Tool'!$M$455='Menu Data'!$A$14,'Amendment Tool'!$M$511='Menu Data'!$A$14,'Amendment Tool'!$M$567='Menu Data'!$A$14,'Amendment Tool'!$M$623='Menu Data'!$A$14),1,0)","v":0},{"$f":"IF(OR('Amendment Tool'!$M$119='Menu Data'!$A$7,'Amendment Tool'!$M$175='Menu Data'!$A$7,'Amendment Tool'!$M$231='Menu Data'!$A$7,'Amendment Tool'!$M$287='Menu Data'!$A$7,'Amendment Tool'!$M$343='Menu Data'!$A$7,'Amendment Tool'!$M$399='Menu Data'!$A$7,'Amendment Tool'!$M$455='Menu Data'!$A$7,'Amendment Tool'!$M$511='Menu Data'!$A$7,'Amendment Tool'!$M$567='Menu Data'!$A$7,'Amendment Tool'!$M$623='Menu Data'!$A$7),1,0)","v":0}]
[null,null,"This amendment includes changes to the research exposures in the study. Part B Section 3 of IRAS should be updated by the appropriate Medical Physics Expert(s) (MPE) and Clinical Radiation Expert(s) (CRE) and provided to the REC as part of the substantial amendment submission. Please note that the MPE and CRE reviews in IRAS can be provided through the Radiation Assurance service if the study already has Radiation Assurance or if the amendment is adding research exposures to the study for the first time. Further information on eligible study types is available",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$67","v":0}]
[null,null,"on the IRAS website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$67","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$67","v":0}]
[null,"Human tissue information to be provided to the REC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$120='Menu Data'!$C$142,'Amendment Tool'!$M$176='Menu Data'!$C$142,'Amendment Tool'!$M$232='Menu Data'!$C$142,'Amendment Tool'!$M$288='Menu Data'!$C$142,'Amendment Tool'!$M$344='Menu Data'!$C$142,'Amendment Tool'!$M$400='Menu Data'!$C$142,'Amendment Tool'!$M$456='Menu Data'!$C$142,'Amendment Tool'!$M$512='Menu Data'!$C$142,'Amendment Tool'!$M$568='Menu Data'!$C$142,'Amendment Tool'!$M$624='Menu Data'!$C$142),1,0)","v":0}]
[null,null,"This amendment adds the use or storage of human tissue samples under the relevant legislation for Human Tissue for the first time. An updated version of the IRAS form for the study should be provided, with Part B Section 4 completed to describe the arrangements regarding the Human Tissue.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$71","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$71","v":0}]
[null,"Change of Chief Investigator (CI) authorisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$120='Menu Data'!$C$107,'Amendment Tool'!$M$176='Menu Data'!$C$107,'Amendment Tool'!$M$232='Menu Data'!$C$107,'Amendment Tool'!$M$288='Menu Data'!$C$107,'Amendment Tool'!$M$344='Menu Data'!$C$107,'Amendment Tool'!$M$400='Menu Data'!$C$107,'Amendment Tool'!$M$456='Menu Data'!$C$107,'Amendment Tool'!$M$512='Menu Data'!$C$107,'Amendment Tool'!$M$568='Menu Data'!$C$107,'Amendment Tool'!$M$624='Menu Data'!$C$107),1,0)","v":0}]
[null,null,"A change to the Chief Investigator or an update of contact details for the current Chief Investigator is required to be submitted individually and approved prior to other amendments being submitted. Before this amendment tool can be submitted, the CI, Project Deputy or a Collaborator for the project will need to update the CI in new IRAS. This will create a new substantial amendment and the new CI will receive a task to confirm ownership and upload their CV. Once this has been completed, the person who created the amendment will receive a notification. At this point, they can upload the amendment tool and any other associated documents and submit the amendment to the sponsor for authorisation in IRAS.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$74","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$74","v":0}]
[null,"Change of sponsor:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$120='Menu Data'!$C$179,'Amendment Tool'!$M$176='Menu Data'!$C$179,'Amendment Tool'!$M$232='Menu Data'!$C$179,'Amendment Tool'!$M$288='Menu Data'!$C$179,'Amendment Tool'!$M$344='Menu Data'!$C$179,'Amendment Tool'!$M$400='Menu Data'!$C$179,'Amendment Tool'!$M$456='Menu Data'!$C$179,'Amendment Tool'!$M$512='Menu Data'!$C$179,'Amendment Tool'!$M$568='Menu Data'!$C$179,'Amendment Tool'!$M$624='Menu Data'!$C$179),1,0)","v":0}]
[null,null,"A change to the sponsor/sponsor legal representative or an update of contact details for the current sponsor/sponsor legal representative is required to be submitted individually and approved prior to other amendments being submitted. Where applicable, the new sponsor should authorise the sponsor declaration page (D2) from the original IRAS form.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$77","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$77","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Notifying participating organisations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$84:$AE$115,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$82","v":0}]
[null,null,"Affected participating NHS/HSC organisations should be notified about the amendment once the amendment has been submitted. Please see below for additional country specific guidance about how to notify participating NHS/HSC organisations about the amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$98:$AE$114,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$84","v":0}]
[null,null,"Affected participating NHS/HSC organisations should be informed about the amendment. Please see below for additional country specific guidance about how to inform participating NHS/HSC organisations about the amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(Arrays!$E$53=Arrays!$A$58,OR(Arrays!$C$11=1,Arrays!$C$15=1,Arrays!$C$19=1)),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$86","v":0}]
[null,null,"Whilst this is a non-notifiable amendment, it still may need to be shared with participating NHS/HSC organisations.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$86","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$86","v":0}]
[null,null,"England and Wales:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$86=1,Arrays!$C$11=1,Arrays!$C$19=0),1,0)","v":0}]
[null,null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$86=1,Arrays!$C$11=0,Arrays!$C$19=1),1,0)","v":0}]
[null,null,"England and Wales and Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$86=1,Arrays!$C$11=1,Arrays!$C$19=1),1,0)","v":0}]
[null,null,"Please share with the research team (e.g. Principal Investigator and their team) and local NHS/HSC R&D offices, via email, so that arrangements can be put in place to implement the amendment. Where this is the case, the local NHS/HSC R&D office is not expected to undertake a governance review and categorise the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$90=1,$AE$91=1,$AE$92=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$93","v":0}]
[null,null,"Scotland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$86=1,Arrays!$C$15=1),1,0)","v":0}]
[null,null,"Please share with the research team only (e.g. Principal Investigator and their team), via email, so that arrangements can be put in place to implement the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$95","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$95","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this study has been processed via Pharmacy Assurance. There could be implications for the information contained in the pharmacy technical review form based on the changes brought in by this amendment, which could have an impact on capacity and capability of participating organisations. Please see the guidance on the IRAS Help pages about which changes could impact on the pharmacy technical review form. There is also a Pharmacy Assurance Amendment Site Notification Form available that can be used to help notify participating organisations about this.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$63=1,'Amendment Tool'!$AF$63=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$98","v":0}]
[null,null,"England and Wales:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(OR(Arrays!$G$11<>\"\",Arrays!$H$11<>\"\"),AND(Arrays!$G$19=\"\",Arrays!$H$19=\"\")),1,0)","v":0}]
[null,null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(AND(Arrays!$G$11=\"\",Arrays!$H$11=\"\"),OR(Arrays!$G$19<>\"\",Arrays!$H$19<>\"\")),1,0)","v":0}]
[null,null,"England and Wales and Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(OR(Arrays!$G$11<>\"\",Arrays!$H$11<>\"\"),OR(Arrays!$G$19<>\"\",Arrays!$H$19<>\"\")),1,0)","v":0}]
[null,null,"Please disseminate the information about the amendment directly to affected NHS organisations in England and Wales as required. Please share with the research team (e.g. Principal Investigator and their team) and the local NHS R&D offices.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$100","v":0}]
[null,null,"Please disseminate the information about the amendment directly to affected HSC organisations in Northern Ireland as required. Please share with the research team (e.g. Principal Investigator and their team) and the local HSC R&D offices.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$101","v":0}]
[null,null,"Please disseminate the information about the amendment directly to affected NHS organisations in England and Wales and affected HSC organisations in Northern Ireland as required. Please share with the research team (e.g. Principal Investigator and their team) and the local NHS/HSC R&D offices.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$102","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$100=1,$AE$101=1,$AE$102=1),1,0)","v":0}]
[null,null,"Scotland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$108=1,$AE$109=1),1,0)","v":0}]
[null,null,"As there is only a single-centre in Scotland, please submit the amendment documentation directly to the NHS Board concerned.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$86=1,0,IF(AND($AF$108=1)*(OR(Arrays!$G$15<>\"\",Arrays!$H$15<>\"\")),1,0))","v":0},{"$f":"IF(AND('Amendment Tool'!$AE$85=1,'Amendment Tool'!$AF$85=1),1,0)","v":0}]
[null,null,"As there are multiple participating organisations, the Coordinating Function will notify participating NHS Health Board Research Offices in Scotland on your behalf following online submission of the amendment. The Coordinating function will email you following submission giving the date for implementation of the amendment, where appropriate. However, as a Sponsor responsibility, please continue to send the amendment documentation directly to the study delivery team at the participating research sites in Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$86=1,0,IF(AND($AF$108=0)*(OR(Arrays!$G$15='Menu Data'!$A$31,Arrays!$H$15='Menu Data'!$A$31)),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$107","v":0}]
[null,null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR($AF$112=1,$AF$113=1),1,0)","v":{"$error":"#REF!"}}]
[null,null,"As there is only a single-centre in Northern Ireland, please submit the amendment documentation directly to the HSC Trust/organisation concerned.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,0]
[null,null,"Please submit the amendment documentation directly to the HSC Trusts/organisations concerned.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF($AE$86=1,0,IF(AND(#REF!=0)*(OR(Arrays!$G$19='Menu Data'!$A$31,Arrays!$H$19='Menu Data'!$A$31)),1,0))","v":{"$error":"#REF!"}}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AF$111","v":{"$error":"#REF!"}}]
[null,null,"Please ensure complete amendment information is disseminated to all non-NHS/HSC organisations affected by this amendment. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF('Amendment Tool'!$AF$78=1,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$82=0,0,1)","v":0}]
[null,"Submitting the amendment to other national review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"This amendment does not need to be submitted to any other national review bodies.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$121=1,0,1)","v":1}]
[null,null,"This amendment should be notified to the following national review bodies:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$123:$AE$209,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"UK wide review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$125:$AE$175,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$123","v":0}]
[null,"Notification of amendment to MHRA Medicines",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$3='Menu Data'!$A$31,1,0)","v":0}]
[null,null,"As this is a substantial amendment to a clinical trial of an investigational medicinal product (CTIMP), it must be notified to MHRA Medicines.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"Your answers indicate that this trial has been processed under the combined review service, therefore the amendment should be created and submitted using the new part of IRAS. For further information on how to do this, please visit our combined review webpage and follow the links to our guidance.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$125=1,'Amendment Tool'!$AF$62=1),1,0)","v":0}]
[null,null,"A locked PDF copy of the amendment tool should be included in your notification to the MHRA. Please note it is no longer necessary to submit a European Commission Form (Annex 2) when notifying substantial amendments to the MHRA.\n\nWe highly recommend referring to the MHRA's website for further details and guidance regarding the information to include as part of your submission (particular care should be taken to ensure the contents of the accompanying cover letter meet the necessary requirements).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"Please note: Fees apply to amendments requiring full review by the MHRA. For details on the MHRA's fees please visit here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"If you require further guidance on notifying substantial amendments to MHRA Medicines, this is available on the MHRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Notification of amendment to MHRA Devices",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$4='Menu Data'!$A$31,Arrays!$H$4='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment to a clinical investigation or other study of a medical device must be notified to MHRA Devices via CI-amendments@mhra.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$134","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"A copy of the completed Amendment Tool",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"The MHRA reference number for the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Details of the proposed change(s) to the clinical investigation plan or design of the device",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"The reason for the change(s) ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"A signed statement by or on behalf of the manufacturer that the proposed change(s) do not predictably increase the risk to the patient, user or third party",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Where files are too large to be emailed, amendments should be submitted on CD via post (3 copies, each copy on a separate CD).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please note: Fees apply to amendments requiring full review by the MHRA. For details on the MHRA's fees please visit here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"If you require further guidance regarding MHRA Devices amendments, this is available on the MHRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Performance evaluation of an in-vitro diagnostic (IVD) medical device in Northern Ireland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$149=1,$AE$150=1),1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this amendment includes a performance evaluation study of an In Vitro Diagnostic (IVD) medical device and that Northern Ireland is being added for the first time. Due to legislative differences between Northern Ireland and Great Britain for studies involving IVD medical devices, this change may require a submission to MHRA Devices to cover the addition of Northern Ireland to the study.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,'Amendment Tool'!$AJ$66)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this amendment changes a study involving Northern Ireland to include a performance evaluation study of an In Vitro Diagnostic (IVD) medical device. Due to legislative differences between Northern Ireland and Great Britain for studies involving IVD medical devices, this change may require a submission to MHRA Devices to cover the addition of Northern Ireland to the study.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,'Amendment Tool'!$AJ$67)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$149=1,$AE$150=1),1,0)","v":0}]
[null,null,"You should continue to submit this amendment in line with the instructions for submitting the amendment to REC and for NHS/HSC review. However, if you have not already done so, you should contact the HSC R&D Approvals Service for support regarding any MHRA Devices submission requirements for Northern Ireland:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$149=1,$AE$150=1),1,0)","v":0}]
[null,null,"You should email research.approvals@hscni.net making sure to note IVDR Amendment Submission and your IRAS number and the amendment number",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$149=1,$AE$150=1),1,0)","v":0}]
[null,null,"somewhere in the email subject line. The email should be sent with high importance. Someone from the HSC R&D Approvals Service will respond as soon as possible.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$149=1,$AE$150=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"AE148","v":0}]
[null,"Notification of amendment to ARSAC",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$5='Menu Data'!$A$31,Arrays!$H$5='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment must be notified to the Administration of Radioactive Substances Advisory Committee (ARSAC) via the ARSAC online portal.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,"A copy of the completed Amendment Tool",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,"An updated Preliminary Assessment Form (PRA) from IRAS (only required where there are changes to the number of administrations or procedures involving radioactive substances). Part B Section 3 of IRAS should be updated by the appropriate Medical Physics Expert(s) (MPE) and Clinical Radiation Expert(s) (CRE), and electronic authorisation provided throughout the PRA",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$5='Menu Data'!$A$31,1,0)","v":0}]
[null,null,"Any relevant amended documentation",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,"Please note: Fees apply to amendments requiring full review by ARSAC. Details of how to pay will be sent to you following submission of the amendment. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$163","v":0}]
[null,null,"If you require further guidance on notifying amendments to ARSAC, this can be viewed here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$156","v":0}]
[null,"Notification of amendment to Radiation Assurance",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$M$1024='Menu Data'!$A$31,1,0)","v":0}]
[null,null,"This amendment to the research exposures should be notified to Radiation Assurance via radiation.assurance@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$167","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$167","v":0}]
[null,null,"An updated research exposure form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"An updated IRAS form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Any relevant amended documentation (such as protocol, participant information sheet(s), imaging manual)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please note: Fees apply to amendments being processed for review through Radiation Assurance. Details of fees and payment processes are available on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Review bodies in England and Wales",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$178:$AE$190,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$176","v":0}]
[null,"Notification of amendment to CAG",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$9='Menu Data'!$A$31,Arrays!$H$9='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment should be notified to the Confidentiality Advisory Team (CAT) by sending them the completed Amendment Tool. The CAT will advise if anything further is required for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$H$9='Menu Data'!$A$31,1,0)","v":0}]
[null,null,"This amendment must be submitted to the Confidentiality Advisory Group (CAG) for full review. To do this, a CAG amendment form should be completed. Further information and access to the form are available here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$9='Menu Data'!$A$31,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$178","v":0}]
[null,null,"You can contact the Confidentiality Advice Team via cag@hra.nhs.uk if you wish to discuss your amendment pre-submission. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$178","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$178","v":0}]
[null,"Notification of amendment to HMPPS",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$10='Menu Data'!$A$31,Arrays!$H$10='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment must be notified to Her Majesty’s Prison and Probation Service (HMPPS) via the National Research Coordinator at",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$184","v":0}]
[null,null,"National.Research@noms.gsi.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"An email explaining the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Any relevant amended documentation",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Review bodies in Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$193:$AE$201,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$191","v":0}]
[null,"Notification of amendment to PBPP",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$13='Menu Data'!$A$31,Arrays!$H$13='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment must be notified to Public Benefit and Privacy Panel for Health (PBPP). To do this, an amendment request form should be completed.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$193","v":0}]
[null,null,"Further information and access to the form are available here. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$193","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$193","v":0}]
[null,null,"Further details can be requested by contacting phs.edris@phs.scot or 0131 275 7333. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$193","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$193","v":0}]
[null,"Notification of amendment to Scottish Prison Service Research Access and Ethics Committee (RAEC)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$14='Menu Data'!$A$31,Arrays!$H$14='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"Contact gram.nrspcc@nhs.scot for advice about submitting amendments to SPS (RAEC).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$199","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$199","v":0}]
[null,"Review bodies in Northern Ireland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$204:$AE$209,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$202","v":0}]
[null,"Notification of amendment to HSC Data Guardians",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$17='Menu Data'!$A$31,Arrays!$H$17='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"This amendment must be reviewed by HSC Data Guardians at the participating HSC Trusts/organisations. The amendment should be submitted to participating HSC Trusts/organisations in Northern Ireland as described above for this review to be undertaken.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$204","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$204","v":0}]
[null,"Notification of amendment to Northern Ireland Prison Service",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$18='Menu Data'!$A$31,Arrays!$H$18='Menu Data'!$A$31),1,0)","v":0}]
[null,null,"Contact research.amendments@hscni.net for advice about submitting amendments to the Northern Ireland Prison Service.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$207","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$207","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Categorisation information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
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[null,null,"This amendment does not need to be categorised for implementation in the NHS/HSC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$E$23=\"\",Arrays!$E$23=Arrays!$A$28),1,0)","v":1}]
[null,null,"This amendment has the following categorisation for implementation in the NHS/HSC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$213=1,0,1)","v":0}]
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[null,null,"A",null,"This is a Category A amendment, meaning it has implications for, or affects, all participating NHS/HSC organisations hosting the research project.\n\nParticipating NHS/HSC organisations have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$23,1,0)","v":0}]
[null,null,"B",null,"This is a Category B amendment, meaning it has implications for, or affects, specific participating NHS/HSC organisations hosting the research project.\n\nParticipating NHS/HSC organisations have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$25,1,0)","v":0}]
[null,null,"B/C",null,"This is a Category B/C amendment, meaning it includes some changes that in isolation would be Category B (i.e. affecting specific NHS/HSC organisations hosting the research project) and some changes that in isolation would be Category C (i.e. which have no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project). Section 4 of the Amendment Tool will make it clear which changes are Category B and which are Category C.\n\nParticipating NHS/HSC organisations affected by the Category B changes will have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.\n\nParticipating NHS/HSC organisations affected by the Category C changes should be provided with the amendment for information; the amendment can be implemented as soon as any required regulatory approvals are in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$24,1,0)","v":0}]
[null,null,"C",null,"This is a Category C amendment, meaning it has no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project. However, the amendment should still be provided for information, and can be implemented as soon as any required regulatory approvals are in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$220=1,0,IF(Arrays!$E$23=Arrays!$A$26,1,0))","v":0}]
[null,null,"C",null,"This is a Category C amendment, meaning it has no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project. However, the amendment should still be provided for information, and can be implemented as soon as any required regulatory approvals are in place.\n\nNote - Updated Investigator Brochure (IB; Clinical Trials of Investigational Medicinal Products (CTIMPs) only): Where the IB update constitutes a non-substantial amendment for REC and MHRA and this is the only amendment (e.g. the update to IB does not give rise to an updated pharmacy manual or protocol) the updated IB should not be submitted for categorisation. These amendments will always be category C and they will not be assessed by NHS/HSC if submitted. The IB should be provided to each participating NHS/HSC organisation.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$K$120='Menu Data'!$C$154,'Amendment Tool'!$K$176=0),1,0)","v":0}]
[null,null,"New\nsite",null,"This amendment solely relates to the addition of one or more new participating NHS/HSC organisations to a study. See below for further information about setting up the new participating NHS/HSC organisation(s).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$27,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$216:$AE$221,1),1,0)","v":0}]
[null,"Setting up new participating NHS/HSC organisation(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AA$1013:$AB$1022=Arrays!$A$27),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$223","v":0}]
[null,null,"Please see below for additional country specific guidance about how to implement your amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$223","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$223","v":0}]
[null,"England and Wales: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AH$8:$AH$98,1),1,0)","v":0}]
[null,null,"For studies which already have HRA and HCRW Approval:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AE$227","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in this needs to be added back in future"]
[null,null,"You can start the process of setting up at the new participating organisation as soon as you have submitted your amendment. You can open the study when that participating NHS organisation has confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$227","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"For studies which do not yet have HRA and HCRW Approval:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AE$227","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in this needs to be added back in future"]
[null,null,"HRA and HCRW Approval for the initial application is pending and you will receive this in due course. You can start the process of setting up the new participating organisation(s) by sharing the Local Information Pack, but the study cannot open at the participating organisation(s) until HRA and HCRW Approval is in place and the participating organisation(s) have confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AE$227","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in this needs to be added back in future"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"$AE$227","v":0},"Disabled for v1.6 with flat 0 in AE; original syntax retained in AF in this needs to be added back in future"]
[null,"Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AI$8:$AI$98,1),1,0)","v":0}]
[null,null,"Please start to set up your new participating organisation(s). Participating organisations may not open until NHS management permission is in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$234","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$234","v":0}]
[null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AJ$8:$AJ$98,1),1,0)","v":0}]
[null,null,"You can start the process of setting up at the new participating organisation(s) as soon as you have submitted your amendment and can open the study when that participating HSC organisation has confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$237","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$237","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Further guidance",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"For further detailed amendment guidance, please visit the IRAS help pages. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"The IRAS website also gives guidance on the definition of a research exposure.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AND('Amendment Tool'!$AE$69=1,'Amendment Tool'!$AF$69=1),(AND('Amendment Tool'!$AE$70=1,'Amendment Tool'!$AF$70=1))),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"If have a query about using the Amendment Tool please contact amendments please contact amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Where an application to a review body is being made for first time because of an amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"If your amendment requires an application to be made to a review body for the first time, please contact your Lead R&D Office for guidance on how to proceed. Guidance on preparing and submitting applications is also available on the IRAS Help pages.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AF$76=1,1,0)","v":1}]
[null,null,"Guidance on preparing and submitting applications is available on the IRAS Help pages.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$249=1,0,1)","v":0}]
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{"sheet":"Glossary of Amendment Options","index":3,"n_rows":244,"n_cols":28,"rows_kept":244,"cut":false,"hidden":false,"merged":[[191,1,191,28],[192,1,192,28],[164,2,164,27],[99,2,99,27],[106,1,106,28],[119,2,119,27],[120,1,120,28],[116,2,116,27],[162,2,162,27],[163,2,163,27],[171,1,171,28],[153,2,153,27],[159,2,159,27],[160,2,160,27],[165,2,165,27],[157,2,157,27],[145,2,145,27],[127,2,127,27],[110,1,110,28],[124,1,124,28],[131,1,131,28],[141,1,141,28],[156,1,156,28],[173,2,173,27],[64,2,64,27],[226,1,226,28],[228,2,228,27],[224,2,224,27],[203,2,203,27],[211,2,211,27],[212,2,212,27],[213,2,213,27],[214,2,214,27],[179,2,179,27],[187,2,187,27],[193,1,193,28],[194,1,194,28],[195,1,195,28],[219,1,219,28],[220,1,220,28],[221,1,221,28],[222,1,222,28],[223,1,223,28],[205,2,205,27],[206,2,206,27],[207,2,207,27],[208,2,208,27],[65,2,65,27],[13,2,13,27],[14,2,14,27],[30,1,30,28],[31,1,31,28],[34,2,34,27],[43,1,43,28],[44,1,44,28],[45,2,45,27],[17,1,17,28],[40,1,40,28],[39,2,39,27],[21,2,21,27],[22,2,22,27],[38,2,38,27],[32,2,32,27],[33,2,33,27],[35,2,35,27],[41,2,41,27],[19,2,19,27],[66,2,66,27],[62,2,62,27],[63,2,63,27],[90,2,90,27],[55,2,55,27],[56,1,56,28],[144,2,144,27],[142,2,142,27],[128,2,128,27],[130,1,130,28],[132,2,132,27],[125,2,125,27],[121,2,121,27],[123,1,123,28],[111,2,111,27],[107,2,107,27],[109,1,109,28],[97,2,97,27],[98,2,98,27],[88,2,88,27],[92,2,92,27],[118,2,118,27],[117,2,117,27],[87,1,87,28],[46,2,46,27],[47,2,47,27],[72,2,72,27],[93,2,93,27],[89,2,89,27],[50,2,50,27],[91,2,91,27],[86,1,86,28],[78,2,78,27],[76,2,76,27],[77,2,77,27],[70,1,70,28],[74,2,74,27],[61,2,61,27],[68,2,68,27],[67,2,67,27],[59,1,59,28],[60,1,60,28],[75,2,75,27],[51,2,51,27],[52,2,52,27],[53,2,53,27],[57,2,57,27],[73,2,73,27],[3,1,3,28],[4,1,4,28],[5,1,5,28],[6,1,6,28],[7,2,7,27],[71,1,71,28],[18,2,18,27],[23,2,23,27],[24,2,24,27],[8,2,8,27],[9,2,9,27],[10,2,10,27],[11,2,11,27],[12,2,12,27],[25,2,25,27],[26,2,26,27],[48,2,48,27],[49,2,49,27],[28,2,28,27],[27,2,27,27],[36,2,36,27],[37,2,37,27],[16,1,16,28],[20,2,20,27],[235,2,235,27],[146,2,146,27],[147,2,147,27],[148,2,148,27],[152,1,152,28],[166,2,166,27],[167,1,167,28],[151,2,151,27],[143,2,143,27],[209,2,209,27],[161,2,161,27],[204,2,204,27],[215,2,215,27],[168,2,168,27],[170,1,170,28],[174,2,174,27],[181,2,181,27],[182,2,182,27],[185,2,185,27],[186,2,186,27],[176,2,176,27],[178,2,178,27],[180,2,180,27],[177,2,177,27],[244,2,244,27],[196,2,196,27],[198,1,198,28],[200,2,200,27],[201,2,201,27],[202,2,202,27],[199,1,199,28],[227,1,227,28],[183,2,183,27],[184,2,184,27],[188,2,188,27],[189,2,189,27],[210,2,210,27],[237,2,237,27],[231,2,231,27],[217,2,217,27],[229,2,229,27],[230,2,230,27],[232,2,232,27],[242,2,242,27],[236,2,236,27],[243,1,243,28],[216,2,216,27],[234,2,234,27],[175,2,175,27],[172,2,172,27],[155,1,155,28],[138,2,138,27],[158,2,158,27],[140,1,140,28],[94,2,94,27],[95,2,95,27],[100,1,100,28],[101,1,101,28],[102,1,102,28],[103,1,103,28],[104,1,104,28],[54,2,54,27],[238,2,238,27],[239,2,239,27],[240,2,240,27],[241,2,241,27],[80,1,80,28],[81,1,81,28],[82,2,82,27],[83,2,83,27],[84,2,84,27],[96,2,96,27],[149,2,149,27],[150,2,150,27],[133,2,133,27],[134,2,134,27],[135,2,135,27],[136,2,136,27],[137,2,137,27],[112,2,112,27],[113,2,113,27],[114,2,114,27],[115,2,115,27],[126,2,126,27],[233,2,233,27]]}
[]
[]
[]
[null,"This page contains details of all of the possible changes that can be selected in the amendment tool and guidance about when these options will be available (Ctrl + F to search)."]
[]
[null,{"$f":"'Menu Data'!A2","v":"Administrative details for the project "}]
[null,"These options cover changes to the administrative details relating to the study. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 This option is only available for studies that are not being processed via the CTIMP combined review service (formerly known as the Combined Ways of\n   Working (CWoW) pilot); for those studies, this change should be entered using the \"Administrative\" option."]
[]
[null,null,"Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff"]
[null,null,"Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder"]
[null,null,"Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)"]
[null,null,"Contact details - Sponsor or representative1","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative"]
[null,null,"Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below"]
[null,null,"Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)"]
[]
[]
[null,{"$f":"'Menu Data'!A3","v":"Confidential patient information arrangements "}]
[null,"These changes relate specifically to studies involving access to confidential patient information without consent, where the common law duty of confidentiality has been set aside (e.g. under section 251 support in England and Wales or equivalent in Scotland). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves access to confidential patient information without consent."]
[]
[null,null,"Confidential patient information being accessed without consent for the first time"]
[null,null,"Data controller"]
[null,null,"Data flows"]
[null,null,"Data items"]
[null,null,"Data processor"]
[null,null,"Data sources"]
[null,null,"Duration"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Purposes of application"]
[]
[]
[null,{"$f":"'Menu Data'!A5","v":"CTIMP IMP "}]
[null,"These changes relate specifically to the arrangements for the IMP in clinical trials of investigational medicinal products (CTIMPs). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it is a CTIMP."]
[]
[null,null,"Change of dosing"]
[null,null,"Change of IMPs"]
[null,null,"Change of mode of administration"]
[null,null,"IMP being added to the study for the first time"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Temporary alternative arrangements to provide participants with IMP (e.g. delivery directly by courier) where there is no increased risk to the participant"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A6","v":"CTIMP safety "}]
[null,"These changes relate specifically to the safety arrangements for clinical trials of investigational medicinal products (CTIMPs). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it is a CTIMP."]
[]
[null,null,"Data - New data or interpretation affecting risk/benefit assessment"]
[null,null,"Data - New data or interpretation of relevance for the Investigator (including updated non-clinical data)"]
[null,null,"Data Monitoring Committee - Update from a data monitoring committee (study should proceed without changes)"]
[null,null,"Data Monitoring Committee - Withdrawal of an independent data monitoring committee"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Study oversight - Additional safety monitoring, not part of an urgent safety measure, but taken on a precautionary basis"]
[null,null,"Study oversight - Change in arrangements for monitoring (e.g. remote instead of on-site) where the new arrangements need to be described in updated information for the participant"]
[null,null,"Study oversight - Reduction in the sponsor’s planned level of monitoring for the study"]
[null,null,"Study oversight - Temporary change in arrangements for monitoring (e.g. remote instead of on-site) where the arrangements will not contradict those previously described to the participant and the necessary security arrangements will be in place."]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A7","v":"Ionising radiation exposure not involving Radioactive Substances "}]
[null,"These changes relate specifically to exposures to ionising radiation not involving the administration of radioactive substances (which has its own separate set of changes within the amendment tool). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves the use of exposures to ionising radiation."]
[]
[null,null,"Addition of a new study population with a different clinical condition for the research exposures"]
[null,null,"Addition or removal of a procedure involving research exposures"]
[null,null,"Changes to the dose of ionising radiation procedures specified by the protocol"]
[null,null,"Changes to the number of research exposures for previously declared research exposures"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Significant changes to the ionising radiation risk statement in the PIS where the meaning of the text is substantially altered"]
[]
[]
[null,{"$f":"'Menu Data'!A8","v":"Medical Devices and related management arrangements "}]
[null,"These changes relate specifically to clinical investigations or other studies of medical devices. These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves a medical device."]
[]
[null,null,"Change to device under investigation"]
[null,null,"Changes requested by REC"]
[null,null,"Medical device(s) being added to the study for the first time"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Protocol/clinical investigation plan/other study documentation - Changes to safety or clinical information relating to medical device"]
[]
[]
[null,{"$f":"'Menu Data'!A10","v":"Other "}]
[null,"This option has been included specifically for changes that may require review by bodies whose applications are managed outside of IRAS e.g. Health and Safety Executive (HSE), Department for Environment and Rural Affairs (DEFRA). If the change does not involve such review bodies, then this option should not be selected."]
[]
[null,null,"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"]
[]
[]
[null,{"$f":"'Menu Data'!A11","v":"Participant Procedures "}]
[null,"These changes relate to the procedures that involve the study participants. The options available vary depending on the selections made in section 1 of\nthe amendment tool:\n1 These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review.\n2 These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review\n   and that it involves adults lacking capacity."]
[]
[null,null,"Amendment following urgent safety measure(s) taken to protect participants1"]
[null,null,"Mental Capacity - Change to the procedures/arrangements involving adults who lose/lack capacity2"]
[null,null,"Mental Capacity - Involvement of adults who lose/lack capacity for the first time2"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Recruitment - Change in identification, approach, recruitment or consent of participants"]
[null,null,"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment1"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A12","v":"Participating Organisations "}]
[null,"These changes relate to the participating organisations which are undertaking research activities for a study. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 This option will not be available when section 1 of the amendment tool has been completed to indicate that the study is a \"single site, self sponsored\"\n   study in England or Wales, as the set up arrangements will be different for any new sites added to the study."]
[]
[null,null,"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"]
[null,null,"Addition of sites undertaking the same activities as existing sites1"]
[null,null,"Early closure or withdrawal of research sites"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs"]
[null,null,"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs"]
[null,null,"PICs - Early closure or withdrawal of Participant Identification Centres"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A13","v":"Prisoners "}]
[null,"These changes relate specifically to the involvement of prisoners or young offenders within the remit of the UK prison services in England, Wales, Scotland or Northern Ireland. These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves prisoners."]
[]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Prison service is being involved in the study for the first time"]
[]
[]
[null,{"$f":"'Menu Data'!A14","v":"Radioactive Substances "}]
[null,"These changes relate specifically to the administration of radioactive substances requiring review by the Administration of Radioactive Substances Advisory Committee (ARSAC). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves administration of radioactive substances."]
[]
[null,null,"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"]
[null,null,"Addition or removal of a procedure involving administration of radioactive substances"]
[null,null,"Changes to the number of administrations of radioactive substances"]
[null,null,"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"]
[null,null,"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"]
[]
[]
[null,{"$f":"'Menu Data'!A15","v":"Researchers "}]
[null,"These changes relate to the researchers involved in the study e.g. the Chief Investigator (CI), Principal Investigators (PIs), or other members of the research team. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 This option is only available for studies that are not being processed via the CTIMP combined review service (formerly known as the Combined Ways of\n   Working (CWoW) pilot); for those studies, this change should be entered using the \"Chief Investigator\" option.\n2 These options are only available when section 1 of the amendment tool has been completed to indicate that the study involves prisoners."]
[]
[null,null,"Changes to the research team (other than CIs or PIs)"]
[null,null,"CI - New CI, or temporary arrangements to cover the absence of a CI1"]
[null,null,"CI - Possible conflict of interest for CI"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"PI - New PI, or temporary arrangements to cover the absence of a PI"]
[null,null,"PI - Possible conflict of interest for PI"]
[null,null,"Prisons - Change involving PI responsible for the study at the prison service2"]
[null,null,"Prisons - Changes to the research team at the prison service (other than CIs or PIs)2"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A16","v":"Stop or Restart "}]
[null,"These changes relate to stopping or restarting the study. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is non-interventional (e.g. not a CTIMP or medical device study).\n2 These options are only available when section 1 of the amendment tool has been completed to indicate that the study is interventional (e.g. a CTIMP or medical device study).\n3 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is a CTIMP."]
[]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Permanent closure or withdrawal of a non-interventional study1"]
[null,null,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant2"]
[null,null,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant2"]
[null,null,"Restart of study following a temporary halt"]
[null,null,"Temporary halt of CTIMP3"]
[null,null,"Temporary halt of non-CTIMP"]
[null,null,"Temporary halt of non-CTIMP due to COVID-19"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A17","v":"Study Design "}]
[null,"These changes relate to the study design."]
[]
[null,null,"Background information - Change that affects scientific value of study"]
[null,null,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)"]
[null,null,"Endpoint/objective - Change to the endpoint or the main objective"]
[null,null,"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study"]
[null,null,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study"]
[null,null,"New arm - Addition of a study arm or placebo/control group"]
[null,null,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Participant numbers - Minor change to sample size"]
[null,null,"Participant numbers - Significant change to sample size"]
[null,null,"Samples - addition of the storage or use of human tissue samples under the relevant legislation on Human Tissue for the first time"]
[null,null,"Samples - minor changes (e.g. to the logistical arrangements for transporting or storing samples)"]
[null,null,"Samples - significant changes (e.g. to the arrangements for removal, storage or use of samples under the relevant legislation on Human Tissue)"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[]
[null,{"$f":"'Menu Data'!A18","v":"Study Documents "}]
[null,"These changes relate to the study documents.\n1 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is a CTIMP."]
[]
[null,null,"Correction of typographical errors"]
[null,null,"CRF/other study data records - Changes in the documentation used by the research team for recording study data"]
[null,null,"GDPR wording - Accepted wording used verbatim"]
[null,null,"GDPR wording - Unaccepted alternative wording used"]
[null,null,"IB - Annual review (no changes except the last review date)1"]
[null,null,"IB, SmPC - Non-substantial changes (e.g. that do not affect risk/benefit assessment)1"]
[null,null,"IB, SmPC - Substantial changes (e.g. affecting the risk/benefit assessment; changing Reference Safety Information)1"]
[null,null,"IMPD - Non-substantial changes1"]
[null,null,"IMPD - Substantial changes (including IMP labels, GMP documents, MIA (IMP), QP declarations)1"]
[null,null,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Post trial information for participants (which does not contradict the protocol)"]
[null,null,"Protocol - Non-substantial changes (e.g. not affecting safety or the scientific value of the trial)"]
[null,null,"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)"]
[null,null,"Translations - Addition of translated versions of participant-facing documentation"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[]
[null,{"$f":"'Menu Data'!A19","v":"Study Management "}]
[null,"These changes relate to the management of the study. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 For studies that are being processed via the CTIMP combined review service (formerly known as the Combined Ways of Working (CWoW) pilot),\n   these changes can be entered by using the \"Sponsor Group\" option."]
[]
[null,null,"Contract/agreement arrangements"]
[null,null,"Equipment arrangements"]
[null,null,"Funding arrangements - Changes that do not affect payments to participants/researchers/sites"]
[null,null,"Funding arrangements - Changes to the payments, benefits or incentives to be received by participants"]
[null,null,"Funding arrangements - Changes to the payments, benefits or incentives to be received by researchers/sites"]
[null,null,"Insurance - Changes to insurance or indemnity arrangements"]
[null,null,"Insurance - Renewal with no change to the level or breadth of cover"]
[null,null,"Non-UK countries - Inclusion or withdrawal of an EU Member State or third country"]
[null,null,"Other minor change - Please specify in the free text below"]
[null,null,"Other significant change - Please specify in the free text below"]
[null,null,"Sponsor - Change of Sponsor, Co-Sponsor, Joint Sponsor or sponsor delegate1"]
[null,null,"Sponsor - Change of Sponsor’s legal representative1"]
[null,null,"Sponsor delegations - Changes to the internal organisation of the sponsor or persons to whom tasks have been delegated"]
[]
[null,"Please note: As the \"other\" options are not specific, they generally carry a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]

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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"An Annex 2 form is only used for a substantial amendment to a Clinical Trial of an Investigational Medicinal Product (CTIMP). Based on the current answers in the amendment tool, an Annex 2 form should not be required for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1)*OR(Arrays!$E$53='Menu Data'!$A$23,Arrays!$E$53='Menu Data'!$A$24,Arrays!$E$53='Menu Data'!$A$25),0,1)","v":1},null,null,null,null,null,1,"United Kingdom"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$5","v":1},null,null,null,null,null,2,"Austria"]
[null,"Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial1)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Guidance notes",{"$f":"IF($R$5=0,1,0)","v":0},null,null,null,null,null,3,"Belgium"]
[null,"NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND  FOR OPINION OF THE ETHICS COMMITTEES IN THE EUROPEAN UNION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},null,null,null,null,null,4,"Bulgaria"]
[null,"For official use:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},null,null,null,null,null,5,"Croatia"]
[null,"Date of receiving the request:",null,null,null,null,null,"Grounds for non acceptance/negative opinion:",null,null,null,null,null,null,null,null,"This section does not need to be completed by the applicant.",0,null,null,null,null,null,6,"Republic of Cyprus"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,7,"Czech Republic"]
[null,"Date of start of procedure:",null,null,null,null,null,"Authorisation/positive opinion: ",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,8,"Denmark"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,9,"Estonia"]
[null,"Competent authority registration number of the trial:",null,null,null,null,null,"Withdrawal of amendment application:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,10,"Finland"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,11,"France"]
[null,"Ethics committee registration number of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,12,"Germany"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,13,"Greece"]
[null,"To be filled in by the applicant:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,14,"Hungary"]
[null,"This form is to be used both for a request to the Competent Authority for authorisation of a substantial amendment and to an Ethics Committee for its opinion on a substantial amendment. Please indicate the relevant purpose in Section A.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,15,"Ireland"]
[null,"A","TYPE OF NOTIFICATION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,16,"Italy"]
[null,"A.1 Member State in which the substantial amendment is being submitted:",null,null,null,null,null,null,null,null,"United Kingdom",null,null,null,null,null,"Drop down list. UK selected by default.",0,null,null,null,null,null,17,"Latvia"]
[null,"A.2 Notification for authorisation to the competent authority:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on Section 4 of the tool",0,{"$f":"T22","v":false},{"$f":"IF('Amendment Tool'!$J$1024='Menu Data'!$A$31,TRUE,FALSE)","v":false},null,null,null,18,"Lithuania"]
[null,"A.3 Notification for authorisation to the ethics committee:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"T23","v":false},{"$f":"IF('Amendment Tool'!$I$1024='Menu Data'!$A$31,TRUE,FALSE)","v":false},null,null,null,19,"Luxembourg"]
[null,"(1) OJ, C82, 30.3.2010, p. 1; hereinafter referred to as 'detailed guidance CT-1'.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,20,"Malta"]
[null,"B","TRIAL IDENTIFICATION (When the amendment concerns more than one trial, repeat this form as necessary.)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,21,"Netherlands"]
[null,"B.1 Does the substantial amendment concern several trials involving the same IMP?2",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false,null,null,null,null,22,"Poland"]
[null,"B.1.1   If yes repeat this section as necessary.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,23,"Portugal"]
[null,"(2) Cf. Section 3.7. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,24,"Romania"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,25,"Slovakia"]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",0,null,null,null,null,null,26,"Slovenia"]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",0,null,null,null,null,null,27,"Spain"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0,null,null,null,null,null,28,"Sweden"]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($R$5=1,0,IF($S$26=FALSE,1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",{"$f":"IF($R$5=1,0,IF($S$26=TRUE,1,0))","v":0},false,{"$f":"IF(AND($S$26=TRUE,$S$36=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$36=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$37","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$37","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$36=TRUE,$S$42=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$42=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$43","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$43","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$42=TRUE,$S$48=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$48=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$49","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$49","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$48=TRUE,$S$54=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$54=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$55","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$55","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C","IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE REQUEST",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"C.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"C.1.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.2","Name of person to contact:",null,null,{"$f":"U64","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$64=FALSE,\"\",IF('Amendment Tool'!$K$984=\"\",\"\",'Amendment Tool'!$K$984))","v":""}]
[null,"C.1.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.6","e-mail:",null,null,{"$f":"U68","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$64=FALSE,\"\",IF('Amendment Tool'!$K$993=\"\",\"\",'Amendment Tool'!$K$993))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2","Legal representative3 of the sponsor in the European Union for the purpose of this trial (if different from the sponsor)",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"C.2.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.2","Name of person to contact:",null,null,{"$f":"U72","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$72=FALSE,\"\",IF('Amendment Tool'!$K$984=\"\",\"\",'Amendment Tool'!$K$984))","v":""}]
[null,"C.2.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.6","e-mail:",null,null,{"$f":"U76","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$72=FALSE,\"\",IF('Amendment Tool'!$K$993=\"\",\"\",'Amendment Tool'!$K$993))","v":""}]
[null,"(3) As stated in Article 19 of Directive 2001/20/EC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D","APPLICANT IDENTIFICATION (please tick the appropriate box)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1","Request for the competent authority",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"D.1.2","Legal representative of the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.1.3","Person or organisation authorised by the sponsor to make the application",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.1.4","Complete below:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"D.1.4.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.2","Name of person to contact:",null,null,{"$f":"U86","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$86=FALSE,\"\",IF('Amendment Tool'!$K$984=\"\",\"\",'Amendment Tool'!$K$984))","v":""}]
[null,"D.1.4.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.6","e-mail:",null,null,{"$f":"U90","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$86=FALSE,\"\",IF('Amendment Tool'!$K$993=\"\",\"\",'Amendment Tool'!$K$993))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.2","Request for the Ethics Committee",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.2.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"D.2.2","Legal representative of the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.3","Person or organisation authorised by the sponsor to make the application",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.4","Investigator in charge of the application if applicable4:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","Co-ordinating investigator (for multicentre trial)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"•","Principal investigator (for single centre trial)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.5","Complete below:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"D.2.5.1","Organisation:",null,null,{"$f":"U100","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the details entered in D.1 above.",0,false,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$85=\"\",\"\",$F$85))","v":""}]
[null,"D.2.5.2","Name of person to contact:",null,null,{"$f":"U101","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF(AND($S$100=FALSE,$S$101=FALSE),\"\",IF($S$100=TRUE,(IF($F$86=\"\",\"\",$F$86)),IF($S$101=TRUE,(IF('Amendment Tool'!$K$984=\"\",\"\",'Amendment Tool'!$K$984)),\"\")))","v":""}]
[null,"D.2.5.3","Address:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$87=\"\",\"\",$F$87))","v":""}]
[null,"D.2.5.4","Telephone number:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$88=\"\",\"\",$F$88))","v":""}]
[null,"D.2.5.5","Fax number:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$89=\"\",\"\",$F$89))","v":""}]
[null,"D.2.5.6","e-mail:",null,null,{"$f":"U105","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF(AND($S$100=FALSE,$S$101=FALSE),\"\",IF($S$100=TRUE,(IF($F$90=\"\",\"\",$F$90)),IF($S$101=TRUE,(IF('Amendment Tool'!$K$993=\"\",\"\",'Amendment Tool'!$K$993)),\"\")))","v":""}]
[null,"(4) According to national legislation.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E","SUBSTANTIAL AMENDMENT IDENTIFICATION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.1","Sponsor's substantial amendment code number, version, date for the clinical trial concerned:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,{"$f":"$U$110","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,"Copies the reference and date from Section 1 of the tool. Edit if required.",0,null,null,{"$f":"IF(OR('Amendment Tool'!$M$8=\"\",'Amendment Tool'!$M$9=\"\"),\"\",CONCATENATE('Amendment Tool'!$M$8,\", \",TEXT('Amendment Tool'!$M$9,\"DD MMMM YYYY\")))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.2","Type of substantial amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on the answers in the tool",0]
[null,"E.2.1","Amendment to information in the CT application form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$48),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$48),FALSE,TRUE)","v":true}]
[null,"E.2.2","Amendment to the protocol",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$49),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$49),FALSE,TRUE)","v":true}]
[null,"E.2.3","Amendment to other documents appended to the initial application form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false,{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$50),FALSE,TRUE)","v":true}]
[null,"E.2.3.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0,null,null,null,null,null,null,"A2 type","A2 reason",null,null,"E.2.3/E.3.7","E.2.4/E.3.7","E.2.3/E.3.8","E.2.4/E.3.8"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S115=TRUE,R118=0),1,0)","v":0}]
[null,null,{"$f":"U118","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C118<>\"\",1,0)","v":0},null,null,{"$f":"IF($AA118=0,\"\",IF($AA118='Menu Data'!$C$154,$W$118,IF($AA118='Menu Data'!$C$155,$W$119,$AA118)))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",{"$f":"'Amendment Tool'!$M$119","v":0},{"$f":"'Amendment Tool'!$AO$1013","v":""},{"$f":"'Amendment Tool'!$AP$1013","v":""},{"$f":"IF(Y118='Menu Data'!$A$50,X118,0)","v":0},null,{"$f":"IF(AND($Y118='Menu Data'!$A$50,$Z118='Menu Data'!$A$64),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$51,$Z118='Menu Data'!$A$64),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$50,$Z118='Menu Data'!$A$65),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$51,$Z118='Menu Data'!$A$65),$X118,0)","v":0}]
[null,null,{"$f":"U119","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C119<>\"\",1,0)","v":0},null,null,{"$f":"IF($AA119=0,\"\",IF($AA119='Menu Data'!$C$154,$W$118,IF($AA119='Menu Data'!$C$155,$W$119,$AA119)))","v":""},null,"Other significant document change that will have additional resource implications for participating organisations",{"$f":"'Amendment Tool'!$M$120","v":0},{"$f":"'Amendment Tool'!$AO$1013","v":""},{"$f":"'Amendment Tool'!$AP$1013","v":""},{"$f":"IF(Y119='Menu Data'!$A$50,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA120=0,\"\",IF($AA120='Menu Data'!$C$154,$W$118,IF($AA120='Menu Data'!$C$155,$W$119,$AA120)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$128","v":0},{"$f":"'Amendment Tool'!$AO$1013","v":""},{"$f":"'Amendment Tool'!$AP$1013","v":""},{"$f":"IF(Y120='Menu Data'!$A$50,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA121=0,\"\",IF($AA121='Menu Data'!$C$154,$W$118,IF($AA121='Menu Data'!$C$155,$W$119,$AA121)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$175","v":0},{"$f":"'Amendment Tool'!$AO$1014","v":""},{"$f":"'Amendment Tool'!$AP$1014","v":""},{"$f":"IF(Y121='Menu Data'!$A$50,X121,0)","v":0},null,{"$f":"IF(AND($Y121='Menu Data'!$A$50,$Z121='Menu Data'!$A$64),$X121,0)","v":0},{"$f":"IF(AND($Y121='Menu Data'!$A$51,$Z121='Menu Data'!$A$64),$X121,0)","v":0},{"$f":"IF(AND($Y121='Menu Data'!$A$50,$Z121='Menu Data'!$A$65),$X121,0)","v":0},{"$f":"IF(AND($Y121='Menu Data'!$A$51,$Z121='Menu Data'!$A$65),$X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA122=0,\"\",IF($AA122='Menu Data'!$C$154,$W$118,IF($AA122='Menu Data'!$C$155,$W$119,$AA122)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$176","v":0},{"$f":"'Amendment Tool'!$AO$1014","v":""},{"$f":"'Amendment Tool'!$AP$1014","v":""},{"$f":"IF(Y122='Menu Data'!$A$50,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA123=0,\"\",IF($AA123='Menu Data'!$C$154,$W$118,IF($AA123='Menu Data'!$C$155,$W$119,$AA123)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$184","v":0},{"$f":"'Amendment Tool'!$AO$1014","v":""},{"$f":"'Amendment Tool'!$AP$1014","v":""},{"$f":"IF(Y123='Menu Data'!$A$50,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA124=0,\"\",IF($AA124='Menu Data'!$C$154,$W$118,IF($AA124='Menu Data'!$C$155,$W$119,$AA124)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$231","v":0},{"$f":"'Amendment Tool'!$AO$1015","v":""},{"$f":"'Amendment Tool'!$AP$1015","v":""},{"$f":"IF(Y124='Menu Data'!$A$50,X124,0)","v":0},null,{"$f":"IF(AND($Y124='Menu Data'!$A$50,$Z124='Menu Data'!$A$64),$X124,0)","v":0},{"$f":"IF(AND($Y124='Menu Data'!$A$51,$Z124='Menu Data'!$A$64),$X124,0)","v":0},{"$f":"IF(AND($Y124='Menu Data'!$A$50,$Z124='Menu Data'!$A$65),$X124,0)","v":0},{"$f":"IF(AND($Y124='Menu Data'!$A$51,$Z124='Menu Data'!$A$65),$X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA125=0,\"\",IF($AA125='Menu Data'!$C$154,$W$118,IF($AA125='Menu Data'!$C$155,$W$119,$AA125)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$232","v":0},{"$f":"'Amendment Tool'!$AO$1015","v":""},{"$f":"'Amendment Tool'!$AP$1015","v":""},{"$f":"IF(Y125='Menu Data'!$A$50,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA126=0,\"\",IF($AA126='Menu Data'!$C$154,$W$118,IF($AA126='Menu Data'!$C$155,$W$119,$AA126)))","v":""},null,null,{"$f":"'Amendment Tool'!$M$240","v":0},{"$f":"'Amendment Tool'!$AO$1015","v":""},{"$f":"'Amendment Tool'!$AP$1015","v":""},{"$f":"IF(Y126='Menu Data'!$A$50,X126,0)","v":0}]
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[null,"E.2.4","Amendment to other documents or information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$51),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$51),FALSE,TRUE)","v":true}]
[null,"E.2.4.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0]
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[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA163=0,\"\",IF(OR($AA163='Menu Data'!$C$19,$AA163='Menu Data'!$C$102,$AA163='Menu Data'!$C$178),$W$151,IF($AA163='Menu Data'!$C$138,$W$152,IF($AA163='Menu Data'!$C$139,$W$153,$AA163))))","v":""},null,null,null,null,null,{"$f":"IF(Y130='Menu Data'!$A$51,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA164=0,\"\",IF(OR($AA164='Menu Data'!$C$19,$AA164='Menu Data'!$C$102,$AA164='Menu Data'!$C$178),$W$151,IF($AA164='Menu Data'!$C$138,$W$152,IF($AA164='Menu Data'!$C$139,$W$153,$AA164))))","v":""},null,null,null,null,null,{"$f":"IF(Y131='Menu Data'!$A$51,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA165=0,\"\",IF(OR($AA165='Menu Data'!$C$19,$AA165='Menu Data'!$C$102,$AA165='Menu Data'!$C$178),$W$151,IF($AA165='Menu Data'!$C$138,$W$152,IF($AA165='Menu Data'!$C$139,$W$153,$AA165))))","v":""},null,null,null,null,null,{"$f":"IF(Y132='Menu Data'!$A$51,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA166=0,\"\",IF(OR($AA166='Menu Data'!$C$19,$AA166='Menu Data'!$C$102,$AA166='Menu Data'!$C$178),$W$151,IF($AA166='Menu Data'!$C$138,$W$152,IF($AA166='Menu Data'!$C$139,$W$153,$AA166))))","v":""},null,null,null,null,null,{"$f":"IF(Y133='Menu Data'!$A$51,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA167=0,\"\",IF(OR($AA167='Menu Data'!$C$19,$AA167='Menu Data'!$C$102,$AA167='Menu Data'!$C$178),$W$151,IF($AA167='Menu Data'!$C$138,$W$152,IF($AA167='Menu Data'!$C$139,$W$153,$AA167))))","v":""},null,null,null,null,null,{"$f":"IF(Y134='Menu Data'!$A$51,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA168=0,\"\",IF(OR($AA168='Menu Data'!$C$19,$AA168='Menu Data'!$C$102,$AA168='Menu Data'!$C$178),$W$151,IF($AA168='Menu Data'!$C$138,$W$152,IF($AA168='Menu Data'!$C$139,$W$153,$AA168))))","v":""},null,null,null,null,null,{"$f":"IF(Y135='Menu Data'!$A$51,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA169=0,\"\",IF(OR($AA169='Menu Data'!$C$19,$AA169='Menu Data'!$C$102,$AA169='Menu Data'!$C$178),$W$151,IF($AA169='Menu Data'!$C$138,$W$152,IF($AA169='Menu Data'!$C$139,$W$153,$AA169))))","v":""},null,null,null,null,null,{"$f":"IF(Y136='Menu Data'!$A$51,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA170=0,\"\",IF(OR($AA170='Menu Data'!$C$19,$AA170='Menu Data'!$C$102,$AA170='Menu Data'!$C$178),$W$151,IF($AA170='Menu Data'!$C$138,$W$152,IF($AA170='Menu Data'!$C$139,$W$153,$AA170))))","v":""},null,null,null,null,null,{"$f":"IF(Y137='Menu Data'!$A$51,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA171=0,\"\",IF(OR($AA171='Menu Data'!$C$19,$AA171='Menu Data'!$C$102,$AA171='Menu Data'!$C$178),$W$151,IF($AA171='Menu Data'!$C$138,$W$152,IF($AA171='Menu Data'!$C$139,$W$153,$AA171))))","v":""},null,null,null,null,null,{"$f":"IF(Y138='Menu Data'!$A$51,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA172=0,\"\",IF(OR($AA172='Menu Data'!$C$19,$AA172='Menu Data'!$C$102,$AA172='Menu Data'!$C$178),$W$151,IF($AA172='Menu Data'!$C$138,$W$152,IF($AA172='Menu Data'!$C$139,$W$153,$AA172))))","v":""},null,null,null,null,null,{"$f":"IF(Y139='Menu Data'!$A$51,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA173=0,\"\",IF(OR($AA173='Menu Data'!$C$19,$AA173='Menu Data'!$C$102,$AA173='Menu Data'!$C$178),$W$151,IF($AA173='Menu Data'!$C$138,$W$152,IF($AA173='Menu Data'!$C$139,$W$153,$AA173))))","v":""},null,null,null,null,null,{"$f":"IF(Y140='Menu Data'!$A$51,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA174=0,\"\",IF(OR($AA174='Menu Data'!$C$19,$AA174='Menu Data'!$C$102,$AA174='Menu Data'!$C$178),$W$151,IF($AA174='Menu Data'!$C$138,$W$152,IF($AA174='Menu Data'!$C$139,$W$153,$AA174))))","v":""},null,null,null,null,null,{"$f":"IF(Y141='Menu Data'!$A$51,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA175=0,\"\",IF(OR($AA175='Menu Data'!$C$19,$AA175='Menu Data'!$C$102,$AA175='Menu Data'!$C$178),$W$151,IF($AA175='Menu Data'!$C$138,$W$152,IF($AA175='Menu Data'!$C$139,$W$153,$AA175))))","v":""},null,null,null,null,null,{"$f":"IF(Y142='Menu Data'!$A$51,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA176=0,\"\",IF(OR($AA176='Menu Data'!$C$19,$AA176='Menu Data'!$C$102,$AA176='Menu Data'!$C$178),$W$151,IF($AA176='Menu Data'!$C$138,$W$152,IF($AA176='Menu Data'!$C$139,$W$153,$AA176))))","v":""},null,null,null,null,null,{"$f":"IF(Y143='Menu Data'!$A$51,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA177=0,\"\",IF(OR($AA177='Menu Data'!$C$19,$AA177='Menu Data'!$C$102,$AA177='Menu Data'!$C$178),$W$151,IF($AA177='Menu Data'!$C$138,$W$152,IF($AA177='Menu Data'!$C$139,$W$153,$AA177))))","v":""},null,null,null,null,null,{"$f":"IF(Y144='Menu Data'!$A$51,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA178=0,\"\",IF(OR($AA178='Menu Data'!$C$19,$AA178='Menu Data'!$C$102,$AA178='Menu Data'!$C$178),$W$151,IF($AA178='Menu Data'!$C$138,$W$152,IF($AA178='Menu Data'!$C$139,$W$153,$AA178))))","v":""},null,null,null,null,null,{"$f":"IF(Y145='Menu Data'!$A$51,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA179=0,\"\",IF(OR($AA179='Menu Data'!$C$19,$AA179='Menu Data'!$C$102,$AA179='Menu Data'!$C$178),$W$151,IF($AA179='Menu Data'!$C$138,$W$152,IF($AA179='Menu Data'!$C$139,$W$153,$AA179))))","v":""},null,null,null,null,null,{"$f":"IF(Y146='Menu Data'!$A$51,X146,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA180=0,\"\",IF(OR($AA180='Menu Data'!$C$19,$AA180='Menu Data'!$C$102,$AA180='Menu Data'!$C$178),$W$151,IF($AA180='Menu Data'!$C$138,$W$152,IF($AA180='Menu Data'!$C$139,$W$153,$AA180))))","v":""},null,null,null,null,null,{"$f":"IF(Y147='Menu Data'!$A$51,X147,0)","v":0}]
[null,"E.2.5","This amendment concerns mainly urgent safety measures already implemented5",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$52),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$52),FALSE,TRUE)","v":true}]
[null,"E.2.6","This amendment is to notify a temporary halt of the trial6",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$53),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$53),FALSE,TRUE)","v":true}]
[null,"E.2.7","This amendment is to request a restart of the trial7",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$54),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$1013:$AO$1022='Menu Data'!$A$54),FALSE,TRUE)","v":true}]
[null,"(5) Cf. Section 3.9. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(6) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(7) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.3","Reasons for the substantial amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on the answers in the tool",0]
[null,"E.3.1","Changes in safety or integrity of trial subjects",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$58),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$58),FALSE,TRUE)","v":true}]
[null,"E.3.2","Changes in interpretation of scientific documents/value of trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$59),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$59),FALSE,TRUE)","v":true}]
[null,"E.3.3","Changes in quality of IMP(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$60),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$60),FALSE,TRUE)","v":true}]
[null,"E.3.4","Changes in conduct or management of trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$61),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$61),FALSE,TRUE)","v":true}]
[null,"E.3.5","Change or addition of principal investigator(s), co-ordinating investigator",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$62),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$62),FALSE,TRUE)","v":true}]
[null,"E.3.6","Change/addition of site(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$63),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$63),FALSE,TRUE)","v":true}]
[null,"E.3.7","Other change",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$64),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$64),FALSE,TRUE)","v":true}]
[null,"E.3.7.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",{"$f":"$R$7","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S195=TRUE,R198=0),1,0)","v":0}]
[null,null,{"$f":"U198","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C198<>\"\",1,0)","v":0},null,null,{"$f":"IF(AC267=0,\"\",V198)","v":""},"Change to administrative details for the project - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W198),1,0)","v":0}]
[null,null,{"$f":"U199","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to administrative details for the project - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W199),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W200),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W201),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W202),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W203),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W204),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W205),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W206),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W207),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W208),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W209),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W210),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W211),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W212),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W213),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W214),1,0)","v":0}]
[null,null,{"$f":"U215","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W215),1,0)","v":0}]
[null,null,{"$f":"U216","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W216),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W217),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W218),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W219),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W220),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W221),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W222),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W223),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W224),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W225),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W226),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W227),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C228<>\"\",1,0)","v":0},null,null,"","Change to study design - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W228),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study design - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W229),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W230),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W231),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W232),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W233),1,0)","v":0}]
[null,null,{"$f":"U234","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA234=0,\"\",IF($AA234='Menu Data'!$C$19,$W$234,IF($AA234='Menu Data'!$C$154,$W$235,IF($AA234='Menu Data'!$C$155,$W$236,$AA234))))","v":""},null,"Other change",null,null,null,{"$f":"IF(Z118='Menu Data'!$A$64,X118,0)","v":0}]
[null,null,{"$f":"U235","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA235=0,\"\",IF($AA235='Menu Data'!$C$19,$W$234,IF($AA235='Menu Data'!$C$154,$W$235,IF($AA235='Menu Data'!$C$155,$W$236,$AA235))))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",null,null,null,{"$f":"IF(Z119='Menu Data'!$A$64,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA236=0,\"\",IF($AA236='Menu Data'!$C$19,$W$234,IF($AA236='Menu Data'!$C$154,$W$235,IF($AA236='Menu Data'!$C$155,$W$236,$AA236))))","v":""},null,"Other significant document change that will have additional resource implications for participating organisations",null,null,null,{"$f":"IF(Z120='Menu Data'!$A$64,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA237=0,\"\",IF($AA237='Menu Data'!$C$19,$W$234,IF($AA237='Menu Data'!$C$154,$W$235,IF($AA237='Menu Data'!$C$155,$W$236,$AA237))))","v":""},null,null,null,null,null,{"$f":"IF(Z121='Menu Data'!$A$64,X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA238=0,\"\",IF($AA238='Menu Data'!$C$19,$W$234,IF($AA238='Menu Data'!$C$154,$W$235,IF($AA238='Menu Data'!$C$155,$W$236,$AA238))))","v":""},null,null,null,null,null,{"$f":"IF(Z122='Menu Data'!$A$64,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA239=0,\"\",IF($AA239='Menu Data'!$C$19,$W$234,IF($AA239='Menu Data'!$C$154,$W$235,IF($AA239='Menu Data'!$C$155,$W$236,$AA239))))","v":""},null,null,null,null,null,{"$f":"IF(Z123='Menu Data'!$A$64,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA240=0,\"\",IF($AA240='Menu Data'!$C$19,$W$234,IF($AA240='Menu Data'!$C$154,$W$235,IF($AA240='Menu Data'!$C$155,$W$236,$AA240))))","v":""},null,null,null,null,null,{"$f":"IF(Z124='Menu Data'!$A$64,X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA241=0,\"\",IF($AA241='Menu Data'!$C$19,$W$234,IF($AA241='Menu Data'!$C$154,$W$235,IF($AA241='Menu Data'!$C$155,$W$236,$AA241))))","v":""},null,null,null,null,null,{"$f":"IF(Z125='Menu Data'!$A$64,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA242=0,\"\",IF($AA242='Menu Data'!$C$19,$W$234,IF($AA242='Menu Data'!$C$154,$W$235,IF($AA242='Menu Data'!$C$155,$W$236,$AA242))))","v":""},null,null,null,null,null,{"$f":"IF(Z126='Menu Data'!$A$64,X126,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA243=0,\"\",IF($AA243='Menu Data'!$C$19,$W$234,IF($AA243='Menu Data'!$C$154,$W$235,IF($AA243='Menu Data'!$C$155,$W$236,$AA243))))","v":""},null,null,null,null,null,{"$f":"IF(Z127='Menu Data'!$A$64,X127,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA244=0,\"\",IF($AA244='Menu Data'!$C$19,$W$234,IF($AA244='Menu Data'!$C$154,$W$235,IF($AA244='Menu Data'!$C$155,$W$236,$AA244))))","v":""},null,null,null,null,null,{"$f":"IF(Z128='Menu Data'!$A$64,X128,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA245=0,\"\",IF($AA245='Menu Data'!$C$19,$W$234,IF($AA245='Menu Data'!$C$154,$W$235,IF($AA245='Menu Data'!$C$155,$W$236,$AA245))))","v":""},null,null,null,null,null,{"$f":"IF(Z129='Menu Data'!$A$64,X129,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA246=0,\"\",IF($AA246='Menu Data'!$C$19,$W$234,IF($AA246='Menu Data'!$C$154,$W$235,IF($AA246='Menu Data'!$C$155,$W$236,$AA246))))","v":""},null,null,null,null,null,{"$f":"IF(Z130='Menu Data'!$A$64,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA247=0,\"\",IF($AA247='Menu Data'!$C$19,$W$234,IF($AA247='Menu Data'!$C$154,$W$235,IF($AA247='Menu Data'!$C$155,$W$236,$AA247))))","v":""},null,null,null,null,null,{"$f":"IF(Z131='Menu Data'!$A$64,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA248=0,\"\",IF($AA248='Menu Data'!$C$19,$W$234,IF($AA248='Menu Data'!$C$154,$W$235,IF($AA248='Menu Data'!$C$155,$W$236,$AA248))))","v":""},null,null,null,null,null,{"$f":"IF(Z132='Menu Data'!$A$64,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA249=0,\"\",IF($AA249='Menu Data'!$C$19,$W$234,IF($AA249='Menu Data'!$C$154,$W$235,IF($AA249='Menu Data'!$C$155,$W$236,$AA249))))","v":""},null,null,null,null,null,{"$f":"IF(Z133='Menu Data'!$A$64,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA250=0,\"\",IF($AA250='Menu Data'!$C$19,$W$234,IF($AA250='Menu Data'!$C$154,$W$235,IF($AA250='Menu Data'!$C$155,$W$236,$AA250))))","v":""},null,null,null,null,null,{"$f":"IF(Z134='Menu Data'!$A$64,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA251=0,\"\",IF($AA251='Menu Data'!$C$19,$W$234,IF($AA251='Menu Data'!$C$154,$W$235,IF($AA251='Menu Data'!$C$155,$W$236,$AA251))))","v":""},null,null,null,null,null,{"$f":"IF(Z135='Menu Data'!$A$64,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA252=0,\"\",IF($AA252='Menu Data'!$C$19,$W$234,IF($AA252='Menu Data'!$C$154,$W$235,IF($AA252='Menu Data'!$C$155,$W$236,$AA252))))","v":""},null,null,null,null,null,{"$f":"IF(Z136='Menu Data'!$A$64,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA253=0,\"\",IF($AA253='Menu Data'!$C$19,$W$234,IF($AA253='Menu Data'!$C$154,$W$235,IF($AA253='Menu Data'!$C$155,$W$236,$AA253))))","v":""},null,null,null,null,null,{"$f":"IF(Z137='Menu Data'!$A$64,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA254=0,\"\",IF($AA254='Menu Data'!$C$19,$W$234,IF($AA254='Menu Data'!$C$154,$W$235,IF($AA254='Menu Data'!$C$155,$W$236,$AA254))))","v":""},null,null,null,null,null,{"$f":"IF(Z138='Menu Data'!$A$64,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA255=0,\"\",IF($AA255='Menu Data'!$C$19,$W$234,IF($AA255='Menu Data'!$C$154,$W$235,IF($AA255='Menu Data'!$C$155,$W$236,$AA255))))","v":""},null,null,null,null,null,{"$f":"IF(Z139='Menu Data'!$A$64,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA256=0,\"\",IF($AA256='Menu Data'!$C$19,$W$234,IF($AA256='Menu Data'!$C$154,$W$235,IF($AA256='Menu Data'!$C$155,$W$236,$AA256))))","v":""},null,null,null,null,null,{"$f":"IF(Z140='Menu Data'!$A$64,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA257=0,\"\",IF($AA257='Menu Data'!$C$19,$W$234,IF($AA257='Menu Data'!$C$154,$W$235,IF($AA257='Menu Data'!$C$155,$W$236,$AA257))))","v":""},null,null,null,null,null,{"$f":"IF(Z141='Menu Data'!$A$64,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA258=0,\"\",IF($AA258='Menu Data'!$C$19,$W$234,IF($AA258='Menu Data'!$C$154,$W$235,IF($AA258='Menu Data'!$C$155,$W$236,$AA258))))","v":""},null,null,null,null,null,{"$f":"IF(Z142='Menu Data'!$A$64,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA259=0,\"\",IF($AA259='Menu Data'!$C$19,$W$234,IF($AA259='Menu Data'!$C$154,$W$235,IF($AA259='Menu Data'!$C$155,$W$236,$AA259))))","v":""},null,null,null,null,null,{"$f":"IF(Z143='Menu Data'!$A$64,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA260=0,\"\",IF($AA260='Menu Data'!$C$19,$W$234,IF($AA260='Menu Data'!$C$154,$W$235,IF($AA260='Menu Data'!$C$155,$W$236,$AA260))))","v":""},null,null,null,null,null,{"$f":"IF(Z144='Menu Data'!$A$64,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA261=0,\"\",IF($AA261='Menu Data'!$C$19,$W$234,IF($AA261='Menu Data'!$C$154,$W$235,IF($AA261='Menu Data'!$C$155,$W$236,$AA261))))","v":""},null,null,null,null,null,{"$f":"IF(Z145='Menu Data'!$A$64,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA262=0,\"\",IF($AA262='Menu Data'!$C$19,$W$234,IF($AA262='Menu Data'!$C$154,$W$235,IF($AA262='Menu Data'!$C$155,$W$236,$AA262))))","v":""},null,null,null,null,null,{"$f":"IF(Z146='Menu Data'!$A$64,X146,0)","v":0}]
[null,null,{"$f":"U263","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA263=0,\"\",IF($AA263='Menu Data'!$C$19,$W$234,IF($AA263='Menu Data'!$C$154,$W$235,IF($AA263='Menu Data'!$C$155,$W$236,$AA263))))","v":""},null,null,null,null,null,{"$f":"IF(Z147='Menu Data'!$A$64,X147,0)","v":0}]
[null,"E.3.8","Other case",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$65),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$1013:$AP$1022='Menu Data'!$A$65),FALSE,TRUE)","v":true}]
[null,"E.3.8.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S264=TRUE,R267=0),1,0)","v":0}]
[null,null,{"$f":"U267","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C267<>\"\",1,0)","v":0},null,null,{"$f":"IF(AC198=0,\"\",V267)","v":""},"Change to administrative details for the project - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W267),1,0)","v":0}]
[null,null,{"$f":"U268","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to administrative details for the project - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W268),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W269),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W270),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W271),1,0)","v":0}]
[null,null,{"$f":"U272","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W272),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W273),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W274),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W275),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W276),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W277),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W278),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W279),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W280),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W281),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W282),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W283),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W284),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W285),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W286),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W287),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W288),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W289),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W290),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W291),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W292),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W293),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W294),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W295),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W296),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C297<>\"\",1,0)","v":0},null,null,"","Change to study design - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W297),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study design - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W298),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W299),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W300),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W301),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W302),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA303=0,\"\",IF($AA303='Menu Data'!$C$19,$W$303,IF($AA303='Menu Data'!$C$154,$W$304,IF($AA303='Menu Data'!$C$155,$W$305,$AA303))))","v":""},null,"Other change",null,null,null,{"$f":"IF(Z118='Menu Data'!$A$65,X118,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA304=0,\"\",IF($AA304='Menu Data'!$C$19,$W$303,IF($AA304='Menu Data'!$C$154,$W$304,IF($AA304='Menu Data'!$C$155,$W$305,$AA304))))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",null,null,null,{"$f":"IF(Z119='Menu Data'!$A$65,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA305=0,\"\",IF($AA305='Menu Data'!$C$19,$W$303,IF($AA305='Menu Data'!$C$154,$W$304,IF($AA305='Menu Data'!$C$155,$W$305,$AA305))))","v":""},null,"Other significant document change that will have additional resource implications for participating organisations",null,null,null,{"$f":"IF(Z120='Menu Data'!$A$65,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA306=0,\"\",IF($AA306='Menu Data'!$C$19,$W$303,IF($AA306='Menu Data'!$C$154,$W$304,IF($AA306='Menu Data'!$C$155,$W$305,$AA306))))","v":""},null,null,null,null,null,{"$f":"IF(Z121='Menu Data'!$A$65,X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA307=0,\"\",IF($AA307='Menu Data'!$C$19,$W$303,IF($AA307='Menu Data'!$C$154,$W$304,IF($AA307='Menu Data'!$C$155,$W$305,$AA307))))","v":""},null,null,null,null,null,{"$f":"IF(Z122='Menu Data'!$A$65,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA308=0,\"\",IF($AA308='Menu Data'!$C$19,$W$303,IF($AA308='Menu Data'!$C$154,$W$304,IF($AA308='Menu Data'!$C$155,$W$305,$AA308))))","v":""},null,null,null,null,null,{"$f":"IF(Z123='Menu Data'!$A$65,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA309=0,\"\",IF($AA309='Menu Data'!$C$19,$W$303,IF($AA309='Menu Data'!$C$154,$W$304,IF($AA309='Menu Data'!$C$155,$W$305,$AA309))))","v":""},null,null,null,null,null,{"$f":"IF(Z124='Menu Data'!$A$65,X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA310=0,\"\",IF($AA310='Menu Data'!$C$19,$W$303,IF($AA310='Menu Data'!$C$154,$W$304,IF($AA310='Menu Data'!$C$155,$W$305,$AA310))))","v":""},null,null,null,null,null,{"$f":"IF(Z125='Menu Data'!$A$65,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA311=0,\"\",IF($AA311='Menu Data'!$C$19,$W$303,IF($AA311='Menu Data'!$C$154,$W$304,IF($AA311='Menu Data'!$C$155,$W$305,$AA311))))","v":""},null,null,null,null,null,{"$f":"IF(Z126='Menu Data'!$A$65,X126,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA312=0,\"\",IF($AA312='Menu Data'!$C$19,$W$303,IF($AA312='Menu Data'!$C$154,$W$304,IF($AA312='Menu Data'!$C$155,$W$305,$AA312))))","v":""},null,null,null,null,null,{"$f":"IF(Z127='Menu Data'!$A$65,X127,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA313=0,\"\",IF($AA313='Menu Data'!$C$19,$W$303,IF($AA313='Menu Data'!$C$154,$W$304,IF($AA313='Menu Data'!$C$155,$W$305,$AA313))))","v":""},null,null,null,null,null,{"$f":"IF(Z128='Menu Data'!$A$65,X128,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA314=0,\"\",IF($AA314='Menu Data'!$C$19,$W$303,IF($AA314='Menu Data'!$C$154,$W$304,IF($AA314='Menu Data'!$C$155,$W$305,$AA314))))","v":""},null,null,null,null,null,{"$f":"IF(Z129='Menu Data'!$A$65,X129,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA315=0,\"\",IF($AA315='Menu Data'!$C$19,$W$303,IF($AA315='Menu Data'!$C$154,$W$304,IF($AA315='Menu Data'!$C$155,$W$305,$AA315))))","v":""},null,null,null,null,null,{"$f":"IF(Z130='Menu Data'!$A$65,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA316=0,\"\",IF($AA316='Menu Data'!$C$19,$W$303,IF($AA316='Menu Data'!$C$154,$W$304,IF($AA316='Menu Data'!$C$155,$W$305,$AA316))))","v":""},null,null,null,null,null,{"$f":"IF(Z131='Menu Data'!$A$65,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA317=0,\"\",IF($AA317='Menu Data'!$C$19,$W$303,IF($AA317='Menu Data'!$C$154,$W$304,IF($AA317='Menu Data'!$C$155,$W$305,$AA317))))","v":""},null,null,null,null,null,{"$f":"IF(Z132='Menu Data'!$A$65,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA318=0,\"\",IF($AA318='Menu Data'!$C$19,$W$303,IF($AA318='Menu Data'!$C$154,$W$304,IF($AA318='Menu Data'!$C$155,$W$305,$AA318))))","v":""},null,null,null,null,null,{"$f":"IF(Z133='Menu Data'!$A$65,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA319=0,\"\",IF($AA319='Menu Data'!$C$19,$W$303,IF($AA319='Menu Data'!$C$154,$W$304,IF($AA319='Menu Data'!$C$155,$W$305,$AA319))))","v":""},null,null,null,null,null,{"$f":"IF(Z134='Menu Data'!$A$65,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA320=0,\"\",IF($AA320='Menu Data'!$C$19,$W$303,IF($AA320='Menu Data'!$C$154,$W$304,IF($AA320='Menu Data'!$C$155,$W$305,$AA320))))","v":""},null,null,null,null,null,{"$f":"IF(Z135='Menu Data'!$A$65,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA321=0,\"\",IF($AA321='Menu Data'!$C$19,$W$303,IF($AA321='Menu Data'!$C$154,$W$304,IF($AA321='Menu Data'!$C$155,$W$305,$AA321))))","v":""},null,null,null,null,null,{"$f":"IF(Z136='Menu Data'!$A$65,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA322=0,\"\",IF($AA322='Menu Data'!$C$19,$W$303,IF($AA322='Menu Data'!$C$154,$W$304,IF($AA322='Menu Data'!$C$155,$W$305,$AA322))))","v":""},null,null,null,null,null,{"$f":"IF(Z137='Menu Data'!$A$65,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA323=0,\"\",IF($AA323='Menu Data'!$C$19,$W$303,IF($AA323='Menu Data'!$C$154,$W$304,IF($AA323='Menu Data'!$C$155,$W$305,$AA323))))","v":""},null,null,null,null,null,{"$f":"IF(Z138='Menu Data'!$A$65,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA324=0,\"\",IF($AA324='Menu Data'!$C$19,$W$303,IF($AA324='Menu Data'!$C$154,$W$304,IF($AA324='Menu Data'!$C$155,$W$305,$AA324))))","v":""},null,null,null,null,null,{"$f":"IF(Z139='Menu Data'!$A$65,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA325=0,\"\",IF($AA325='Menu Data'!$C$19,$W$303,IF($AA325='Menu Data'!$C$154,$W$304,IF($AA325='Menu Data'!$C$155,$W$305,$AA325))))","v":""},null,null,null,null,null,{"$f":"IF(Z140='Menu Data'!$A$65,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA326=0,\"\",IF($AA326='Menu Data'!$C$19,$W$303,IF($AA326='Menu Data'!$C$154,$W$304,IF($AA326='Menu Data'!$C$155,$W$305,$AA326))))","v":""},null,null,null,null,null,{"$f":"IF(Z141='Menu Data'!$A$65,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA327=0,\"\",IF($AA327='Menu Data'!$C$19,$W$303,IF($AA327='Menu Data'!$C$154,$W$304,IF($AA327='Menu Data'!$C$155,$W$305,$AA327))))","v":""},null,null,null,null,null,{"$f":"IF(Z142='Menu Data'!$A$65,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA328=0,\"\",IF($AA328='Menu Data'!$C$19,$W$303,IF($AA328='Menu Data'!$C$154,$W$304,IF($AA328='Menu Data'!$C$155,$W$305,$AA328))))","v":""},null,null,null,null,null,{"$f":"IF(Z143='Menu Data'!$A$65,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA329=0,\"\",IF($AA329='Menu Data'!$C$19,$W$303,IF($AA329='Menu Data'!$C$154,$W$304,IF($AA329='Menu Data'!$C$155,$W$305,$AA329))))","v":""},null,null,null,null,null,{"$f":"IF(Z144='Menu Data'!$A$65,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA330=0,\"\",IF($AA330='Menu Data'!$C$19,$W$303,IF($AA330='Menu Data'!$C$154,$W$304,IF($AA330='Menu Data'!$C$155,$W$305,$AA330))))","v":""},null,null,null,null,null,{"$f":"IF(Z145='Menu Data'!$A$65,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA331=0,\"\",IF($AA331='Menu Data'!$C$19,$W$303,IF($AA331='Menu Data'!$C$154,$W$304,IF($AA331='Menu Data'!$C$155,$W$305,$AA331))))","v":""},null,null,null,null,null,{"$f":"IF(Z146='Menu Data'!$A$65,X146,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA332=0,\"\",IF($AA332='Menu Data'!$C$19,$W$303,IF($AA332='Menu Data'!$C$154,$W$304,IF($AA332='Menu Data'!$C$155,$W$305,$AA332))))","v":""},null,null,null,null,null,{"$f":"IF(Z147='Menu Data'!$A$65,X147,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"E.4","Information on temporary halt of trial8",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.4.1","Date of temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter date if applicable, it will default to YYYY/MM/DD format.",0]
[null,"E.4.2","Recruitment has been stopped",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"E.4.3","Treatment has been stopped",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"E.4.4","Number of patients still receiving treatment at time of the temporary halt in the MS concerned",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"by the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter number if applicable.",0]
[null,"E.4.5","Briefly describe (free text):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","Justification for a temporary halt of the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The proposed management of patients receiving treatment at time of the halt (free text).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The consequences of the temporary halt for the evaluation of the results and for overall risk benefit assessment of the investigational medicinal product (free text).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,{"$f":"U344","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on any free text entered for a temporary halt of study in Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0,null,null,{"$f":"IF('Amendment Tool'!$M$120='Menu Data'!$C$120,'Amendment Tool'!$M$128,IF('Amendment Tool'!$M$176='Menu Data'!$C$120,'Amendment Tool'!$M$184,IF('Amendment Tool'!$M$232='Menu Data'!$C$120,'Amendment Tool'!$M$240,IF('Amendment Tool'!$M$288='Menu Data'!$C$120,'Amendment Tool'!$M$296,IF('Amendment Tool'!$M$344='Menu Data'!$C$120,'Amendment Tool'!$M$352,IF('Amendment Tool'!$M$400='Menu Data'!$C$120,'Amendment Tool'!$M$408,IF('Amendment Tool'!$M$456='Menu Data'!$C$120,'Amendment Tool'!$M$464,IF('Amendment Tool'!$M$512='Menu Data'!$C$120,'Amendment Tool'!$M$520,IF('Amendment Tool'!$M$568='Menu Data'!$C$120,'Amendment Tool'!$M$576,IF('Amendment Tool'!$M$624='Menu Data'!$C$120,'Amendment Tool'!$M$632,\"\"))))))))))","v":""}]
[null,"(8) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"F","DESCRIPTION OF EACH SUBSTANTIAL AMENDMENT9 (free text):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Previous and new wording in track change modus",null,null,null,"New wording",null,null,null,"Comments/explanations/reasons for substantial amendment",null,null,null,null,null,null,"Consider submitting this documentation on a separate sheet as suggested in footnote 9 that applies to section F of the Annex 2 form.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R349=1,S349=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R350=1,S350=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R351=1,S351=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,"(9) Cf. Section 3.7.c. of the detailed guidance CT-1. The sponsor may submit this documentation on a separate sheet.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G","CHANGE OF CLINICAL TRIAL SITE(S)/INVESTIGATOR(S) IN THE MEMBER STATE CONCERNED BY THIS AMENDMENT",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1","Type of change",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"G.1.1","Addition of a new site",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1","Principal investigator (provide details below)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.2","Middle name (if applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2","Removal of an existing site",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1","Principal investigator (provide details below)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.2","Middle name (if applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3","Change of co-ordinating investigator (provide details below of the new coordinating investigator)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.2","Middle name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.6","Indicate the name of the previous co-ordinating investigator:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4","Change of principal investigator at an existing site (provide details below of the new principal investigator)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.2","Middle name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.6","Indicate the name of the previous co-ordinating investigator:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H","CHANGE OF INSTRUCTIONS TO CA FOR FEEDBACK TO SPONSOR",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.1","Change of e-mail contact for feedback on application*",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2","Change to request to receive an .xml copy of CTA data",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"H.2.1","Do you want a .xml file copy of the CTA form saved on EudraCT?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"H.2.1.1","If yes provide the e-mail address(es) to which it should be sent (up to 5 addresses):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter as required. Must be a valid email address format.",{"$f":"IF($R$5=1,0,IF($S$406=FALSE,0,$R$7))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$408","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$408","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2.2","Do you want to receive this via password protected link(s)10?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",{"$f":"$R$7","v":0}]
[null,"If you answer no to question H.2.2 the .xml file will be transmitted by less secure e-mail link(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2.3","Do you want to stop messages to an email for which they were previously requested?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"H.2.3.1","If yes provide the e-mail address(es) to which feedback should no longer be sent:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter as required. Must be a valid email address format.",{"$f":"IF($R$5=1,0,IF($S$415=FALSE,0,$R$7))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$417","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$417","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(*This will only come into effect from the time at which the request is processed in EudraCT).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"(10) This requires a EudraLink account. (See https://eudract.ema.europa.eu/ for details)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I","LIST OF THE DOCUMENTS APPENDED TO THE NOTIFICATION FORM (cf. Section 3.7 of detailed guidance CT-1)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please submit only relevant documents and/or when applicable make clear references to the new ones already submitted. Make clear references to any changes of separate pages and submit old and new texts. Tick the appropriate box(es).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.1","Cover letter",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"I.2","Extract from the amended document in accordance with Section 3.7.c. of detailed guidance\nCT-1 (if not contained in Part F of this form)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.3","Entire new version of the document11",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.4","Supporting information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.5","Revised .xml file and copy of initial application form with amended data highlighted",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.6","Comments on any novel aspect of the amendment if any:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,"(11) Cf. Section 3.7.c. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J","SIGNATURE OF THE APPLICANT IN THE MEMBER STATE",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.1","I hereby confirm that/confirm on behalf of the sponsor that (delete which is not applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The above information given on this request is correct;",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The trial will be conducted according to the protocol, national regulation and the principles of good clinical practice; and",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","It is reasonable for the proposed amendment to be undertaken.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.2","APPLICANT OF THE REQUEST FOR THE COMPETENT AUTHORITY\n(as stated in section D.1):",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick box will automatically select based on A.2",0,{"$f":"$S$22","v":false}]
[null,"J.2.1","Signature12:",null,null,null,null,null,null,null,null,null,null,null,null,null,"To insert an image of a signature, right click the signature field: Change Picture > From a File, then select the file containing the signature image.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Per the MHRA guidance, the CESP User ID can be entered in the signature field. Enter it here if using.",0]
[null,"J.2.2","Print name:",null,{"$f":"U446","v":""},null,null,null,null,null,null,null,null,null,null,null,"Copies the name based on the answer to D.1. Edit if required.",0,null,null,{"$f":"IF($S$443=FALSE,\"\",$V$446)","v":""},{"$f":"IF($S$81=TRUE,$F$64,IF($S$82=TRUE,$F$72,IF($S$83=TRUE,$F$86,\"\")))","v":""}]
[null,"J.2.3","Date:",null,{"$f":"U447","v":""},null,null,null,null,null,null,null,null,null,null,null,"Automatically uses today's date. Edit if required.",0,null,null,{"$f":"IF($S$443=TRUE,TODAY(),\"\")","v":""}]
[null,"(12) On an application to the Competent Authority only, the applicant to the Competent Authority needs to sign.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.3","APPLICANT OF THE REQUEST FOR THE ETHICS COMMITTEE\n(as stated in section D.2):",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick box will automatically select based on A.3",0,{"$f":"$S$23","v":false}]
[null,"J.3.1","Signature13:",null,null,null,null,null,null,null,null,null,null,null,null,null,"To insert an image of a signature, right click the signature field: Change Picture > From a File, then select the file containing the signature image.",0]
[null,"J.3.2","Print name:",null,{"$f":"U452","v":""},null,null,null,null,null,null,null,null,null,null,null,"Copies the name based on the answer to D.2. Edit if required.",0,null,null,{"$f":"IF($S$450=FALSE,\"\",$V$452)","v":""},{"$f":"IF($S$93=TRUE,$F$64,IF($S$94=TRUE,$F$72,IF((OR($S$95=TRUE,$S$97=TRUE,$S$98=TRUE)),$F$101,\"\")))","v":""}]
[null,"J.3.3","Date:",null,{"$f":"U453","v":""},null,null,null,null,null,null,null,null,null,null,null,"Automatically uses today's date. Edit if required.",0,null,null,{"$f":"IF($S$450=TRUE,TODAY(),\"\")","v":""}]
[null,"(13) On an application to the Ethics Committee only, the applicant to the Ethics Committee needs to sign.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Please note: This button will only become available when all mandatory (*) fields have been completed on the \"Amendment Tool\" tab. When the button is available, clicking it will generate a PDF copy of the Annex 2 form that can be included in the amendment submission. Please ensure that the Annex 2 form is contains all of the intended information before locking it for submission.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"'Amendment Tool'!$AN$997","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]

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["Administrative details for the project ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$3:$Z$8,1)","v":6},null,"Administrative_details_for_the_project_5/6"]
["Confidential patient information arrangements ",{"$f":"LEN(C3)","v":43},"Contact details - CI or other project staff",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$87","v":"N/A"},1,{"$f":"IF($Z3>0,$C3,0)","v":"Contact details - CI or other project staff"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A1)))","v":"Contact details - CI or other project staff"}]
["CTIMP documents ",24,"Contact details - Funder",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N","(Y)",{"$f":"$A$33","v":"N"},"N","N","(Y)",{"$f":"$A$33","v":"N"},"N","N","(Y)","C",{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},"N/A",1,"Contact details - Funder",{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A2)))","v":"Contact details - Funder"}]
["CTIMP IMP ",58,"Contact details - Insurer (insurance arrangements ongoing)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)","C",{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},"N/A",1,"Contact details - Insurer (insurance arrangements ongoing)",{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A3)))","v":"Contact details - Insurer (insurance arrangements ongoing)"}]
["CTIMP safety ",43,"Contact details - Sponsor or representative",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)","C",{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$64","v":"E.3.7"},"N/A",{"$f":"IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1),0,1)","v":1},"Contact details - Sponsor or representative",{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A4)))","v":"Contact details - Sponsor or representative"}]
["Ionising radiation exposure not involving Radioactive Substances ",67,"Other administrative change - Please specify in the free text below",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)","C",{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},"N/A",1,"Other administrative change - Please specify in the free text below",{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other administrative change - Please specify in the free text below"}]
["Medical Devices and related management arrangements ",64,"Project identification (e.g. change of title, reference numbers)",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},"N","(Y)","N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","(Y)","C",{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},"N/A",1,"Project identification (e.g. change of title, reference numbers)",{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A6)))","v":"Project identification (e.g. change of title, reference numbers)"}]
["MoDREC ",0]
["Other ",50,"Confidential_patient_information_arrangements_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Participant Procedures ",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$12:$Z$20,1)","v":9},null,"Confidential_patient_information_arrangements_9"]
["Participating Organisations ",82,"Confidential patient information being accessed without consent for the first time",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z12>0,$C12,0)","v":"Confidential patient information being accessed without consent for the first time"},{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A1)))","v":"Confidential patient information being accessed without consent for the first time"}]
["Prisoners ",15,"Data controller","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data controller",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A2)))","v":"Data controller"}]
["Radioactive Substances ",10,"Data flows","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data flows",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A3)))","v":"Data flows"}]
["Researchers ",10,"Data items","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data items",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A4)))","v":"Data items"}]
["Stop or Restart ",14,"Data processor","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data processor",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A5)))","v":"Data processor"}]
["Study Design ",12,"Data sources","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data sources",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A6)))","v":"Data sources"}]
["Study Documents ",8,"Duration",{"$f":"$A$32","v":"(Y)"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","Y","N",{"$f":"$A$32","v":"(Y)"},"N","Y","N",{"$f":"$A$32","v":"(Y)"},"N","Y","N",{"$f":"$A$32","v":"(Y)"},"V","E.2.4","E.3.7","Part 2",1,"Duration",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A7)))","v":"Duration"}]
["Study Management ",45,"Other - Please specify in the free text below","Y","N","Y","N","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"V","E.2.4","E.3.7","Part 2",1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A8)))","v":"Other - Please specify in the free text below"}]
[null,23,"Purposes of application","Y","N","Y","N","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"N","Y","N",{"$f":"$A$31","v":"Y"},"V","E.2.4","E.3.7","Part 2",1,"Purposes of application",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A9)))","v":"Purposes of application"}]
["Type",0]
["Substantial",14,"CTIMP_IMP_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Substantial for review",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$24:$Z$29,1)","v":6},null,"CTIMP_IMP_6"]
["Substantial for information",16,"Change of dosing",{"$f":"$A$31","v":"Y"},"Y","Y",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z24>0,$C24,0)","v":"Change of dosing"},{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A1)))","v":"Change of dosing"}]
["Substantial New Site/PI only",14,"Change of IMPs","Y","Y","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$60","v":"E.3.3"},{"$f":"$A$88","v":"Part 1"},1,"Change of IMPs",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A2)))","v":"Change of IMPs"}]
["Non-substantial",32,"Change of mode of administration","Y","Y","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Change of mode of administration",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A3)))","v":"Change of mode of administration"}]
["Non-substantial, no study-wide review required",47,"IMP being added to the study for the first time","Y","Y","Y","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"IMP being added to the study for the first time",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A4)))","v":"IMP being added to the study for the first time"}]
["Non-notifiable",45,"Other - Please specify in the free text below","Y","Y","Y","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$88","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
[null,155,"Temporary alternative arrangements to provide participants with IMP (e.g. delivery directly by courier) where there is no increased risk to the participant",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Temporary alternative arrangements to provide participants with IMP (e.g. delivery directly by courier) where there is no increased risk to the participant",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A6)))","v":"Temporary alternative arrangements to provide participants with IMP (e.g. delivery directly by courier) where there is no increased risk to the participant"}]
["Reviews_Notifications",0]
["Y",17,"CTIMP_safety_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["(Y)",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$33:$Z$41,1)","v":9},null,"CTIMP_safety_9"]
["N",67,"Data - New data or interpretation affecting risk/benefit assessment",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z33>0,$C33,0)","v":"Data - New data or interpretation affecting risk/benefit assessment"},{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A1)))","v":"Data - New data or interpretation affecting risk/benefit assessment"}]
["W",105,"Data - New data or interpretation of relevance for the Investigator (including updated non-clinical data)",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},1,"Data - New data or interpretation of relevance for the Investigator (including updated non-clinical data)",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A2)))","v":"Data - New data or interpretation of relevance for the Investigator (including updated non-clinical data)"}]
["Z",{"$f":"LEN(C35)","v":106},"Data Monitoring Committee - Update from a data monitoring committee (study should proceed without changes)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Data Monitoring Committee - Update from a data monitoring committee (study should proceed without changes)",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A3)))","v":"Data Monitoring Committee - Update from a data monitoring committee (study should proceed without changes)"}]
["Q",82,"Data Monitoring Committee - Withdrawal of an independent data monitoring committee",{"$f":"$A$31","v":"Y"},"Y","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Data Monitoring Committee - Withdrawal of an independent data monitoring committee",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A4)))","v":"Data Monitoring Committee - Withdrawal of an independent data monitoring committee"}]
[null,45,"Other - Please specify in the free text below","Y","Y","Y","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$88","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
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["C",0]
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["N/A",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$45:$Z$50,1)","v":6},null,"Ionising_radiation_exposure_not_involving_Radioactive_Substances_6"]
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["E.2.2",45,"Other - Please specify in the free text below","Y","N","Y","N","Y","Y","N","N","N","Y","N","N","N","Y","N","N","N","Y","V",{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$45:$AA$50,SMALL(IF(ISTEXT($AA$45:$AA$50),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
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["E.2.4",0]
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["N/A",24,"Changes requested by REC",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z55>0,$C55,0)","v":"Changes requested by REC"},{"$f":"INDEX($AA$54:$AA$58,SMALL(IF(ISTEXT($AA$54:$AA$58),ROW($AA$1:$AA$5),\"\"),ROW(A2)))","v":"Changes requested by REC"}]
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["E.3.2",0]
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["E.3.6",0]
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["E.3.8",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$66,1)","v":1},null,"Other_1"]
["N/A",87,"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z66>0,$C66,0)","v":"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"},{"$f":"INDEX($AA$66,SMALL(IF(ISTEXT($AA$66),ROW($AA$1:$AA$1),\"\"),ROW(A1)))","v":"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"}]
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["CWoW",27,"Participant_Procedures_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["No P1/2 - Administrative change",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$70:$Z$79,1)","v":8},null,"Participant_Procedures_6/8/10"]
["No P1/2 - CI change",74,"Amendment following urgent safety measure(s) taken to protect participants",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$52","v":"E.2.5"},{"$f":"$A$58","v":"E.3.1"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF('Amendment Tool'!$AF$53=1,1,0)","v":1},{"$f":"IF($Z70>0,$C70,0)","v":"Amendment following urgent safety measure(s) taken to protect participants"},{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A1)))","v":"Amendment following urgent safety measure(s) taken to protect participants"}]
["No P1/2 - Sponsor change",95,"Mental Capacity - Change to the procedures/arrangements involving adults who lose/lack capacity",{"$f":"$A$34","v":"W"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$72=1,'Amendment Tool'!$AF$72=1),1,0)","v":0},0,{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A2)))","v":"Other - Please specify in the free text below"}]
["Part 1 - \"compliance with GMP\"",81,"Mental Capacity - Involvement of adults who lose/lack capacity for the first time",{"$f":"$A$34","v":"W"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$34","v":"W"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$72=1,'Amendment Tool'!$AF$72=1),1,0)","v":0},0,{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A3)))","v":"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below"}]
["Part 1 - \"protocol\"",45,"Other - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A4)))","v":"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Part 1 - \"protocol\"?",157,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A5)))","v":"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below"}]
["Part 1 - \"temporary halt\"",157,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A6)))","v":"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Part 1 - IB, IMPD ish etc.",163,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$42","v":"C"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A7)))","v":"Recruitment - Change in identification, approach, recruitment or consent of participants"}]
["Part 1 - IB, IMPD ish etc. Split needed?",163,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A8)))","v":"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment"}]
["Part 1?",88,"Recruitment - Change in identification, approach, recruitment or consent of participants",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Recruitment - Change in identification, approach, recruitment or consent of participants",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A9)))","v":{"$error":"#NUM!"}}]
["Part 2 - \"data protection\"",122,"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$58","v":"E.3.1"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF('Amendment Tool'!$AF$53=1,1,0)","v":1},"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A10)))","v":{"$error":"#NUM!"}}]
["Part 2 - \"insurance\"",0]
["Part 2 - \"new site\"",32,"Participating_Organisations_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Part 2 - \"new/change to investigator/site\"",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$83:$Z$89,1)","v":6},null,"Participating_Organisations_1/2/6/7"]
["Part 2 - \"participant information\"",110,"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites",{"$f":"$A$35","v":"Z"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"IF(OR('Amendment Tool'!$AJ$100=1,'Amendment Tool'!$AK$100=1),'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"IF('Amendment Tool'!$AL$100=1,'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"IF('Amendment Tool'!$AM$100=1,'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$63","v":"E.3.6"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z83>0,$C83,0)","v":"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"},{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A1)))","v":"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"}]
["Part 2 - \"PIS,CF, other, questionnaires\" - need to be more granular? Need to split out inv letter?",67,"Addition of sites undertaking the same activities as existing sites",{"$f":"$A$35","v":"Z"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$36","v":"Q"},{"$f":"IF(OR('Amendment Tool'!$AJ$100=1,'Amendment Tool'!$AK$100=1),'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$36","v":"Q"},{"$f":"IF('Amendment Tool'!$AL$100=1,'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},"N","N",{"$f":"$A$36","v":"Q"},{"$f":"IF('Amendment Tool'!$AM$100=1,'Menu Data'!$A$34,'Menu Data'!$A$33)","v":"N"},"N","N",{"$f":"$A$36","v":"Q"},{"$f":"IF('Amendment Tool'!$AI$100=1,'Menu Data'!$A$45,'Menu Data'!$A$43)","v":"New site"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$63","v":"E.3.6"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$84=1,'Amendment Tool'!$AF$84=1),0,1)","v":0},0,{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A2)))","v":"Early closure or withdrawal of research sites"}]
["Part 2 - \"recruitment process\"",45,"Early closure or withdrawal of research sites",{"$f":"$A$35","v":"Z"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$63","v":"E.3.6"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"Early closure or withdrawal of research sites",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A3)))","v":"Other - Please specify in the free text below"}]
["Part 2?",45,"Other - Please specify in the free text below",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$63","v":"E.3.6"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"Other - Please specify in the free text below",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A4)))","v":"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs"}]
["N/A",127,"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A5)))","v":"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs"}]
["Part 1",102,"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$43","v":"New site"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A6)))","v":"PICs - Early closure or withdrawal of Participant Identification Centres"}]
["Part 2",72,"PICs - Early closure or withdrawal of Participant Identification Centres",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"PICs - Early closure or withdrawal of Participant Identification Centres",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A7)))","v":{"$error":"#NUM!"}}]
[null,0]
["Specific study",14,"Prisoners_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Research tissue bank",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$93:$Z$94,1)","v":2},null,"Prisoners_2"]
["Research database",45,"Other - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z93>0,$C93,0)","v":"Other - Please specify in the free text below"},{"$f":"INDEX($AA$93:$AA$94,SMALL(IF(ISTEXT($AA$93:$AA$94),ROW($AA$1:$AA$2),\"\"),ROW(A1)))","v":"Other - Please specify in the free text below"}]
[null,64,"Prison service is being involved in the study for the first time",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z94>0,$C94,0)","v":"Prison service is being involved in the study for the first time"},{"$f":"INDEX($AA$93:$AA$94,SMALL(IF(ISTEXT($AA$93:$AA$94),ROW($AA$1:$AA$2),\"\"),ROW(A2)))","v":"Prison service is being involved in the study for the first time"}]
["NHS/HSC REC",0]
["Ministry of Defence (MoDREC)",27,"Radioactive_Substances_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
[null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$98:$Z$102,1)","v":5},null,"Radioactive_Substances_5"]
["England",164,"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"Y","Y","Y",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z98>0,$C98,0)","v":"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A1)))","v":"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"}]
["Wales",{"$f":"LEN(C99)","v":85},"Addition or removal of a procedure involving administration of radioactive substances",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z99>0,$C99,0)","v":"Addition or removal of a procedure involving administration of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A2)))","v":"Addition or removal of a procedure involving administration of radioactive substances"}]
["Scotland",66,"Changes to the number of administrations of radioactive substances",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z100>0,$C100,0)","v":"Changes to the number of administrations of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A3)))","v":"Changes to the number of administrations of radioactive substances"}]
["Northern Ireland",135,"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z101>0,$C101,0)","v":"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A4)))","v":"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"}]
[null,96,"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,{"$f":"IF($Z102>0,$C102,0)","v":"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A5)))","v":"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"}]
["Chief Investigator",0]
["Sponsor",16,"Researchers_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Administrative",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$106:$Z$113,1)","v":6},null,"Researchers_1/2/3/4/5/6/7/8"]
["Project Information",52,"Changes to the research team (other than CIs or PIs)",{"$f":"$A$33","v":"N"},"N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N",{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},{"$f":"IF($Z106>0,$C106,0)","v":"Changes to the research team (other than CIs or PIs)"},{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A1)))","v":"Changes to the research team (other than CIs or PIs)"}]
["New site/PI only",67,"CI - New CI, or temporary arrangements to cover the absence of a CI",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$62","v":"E.3.5"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1),0,1))","v":1},"CI - New CI, or temporary arrangements to cover the absence of a CI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A2)))","v":"CI - New CI, or temporary arrangements to cover the absence of a CI"}]
[null,41,"CI - Possible conflict of interest for CI",{"$f":"$A$31","v":"Y"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$65","v":"E.3.8"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"CI - Possible conflict of interest for CI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A3)))","v":"CI - Possible conflict of interest for CI"}]
["Yes",45,"Other - Please specify in the free text below",{"$f":"$A$33","v":"N"},"N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"Other - Please specify in the free text below",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A4)))","v":"Other - Please specify in the free text below"}]
["No",67,"PI - New PI, or temporary arrangements to cover the absence of a PI",{"$f":"$A$35","v":"Z"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$62","v":"E.3.5"},{"$f":"$A$89","v":"Part 2"},1,"PI - New PI, or temporary arrangements to cover the absence of a PI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A5)))","v":"PI - New PI, or temporary arrangements to cover the absence of a PI"}]
[null,41,"PI - Possible conflict of interest for PI",{"$f":"$A$35","v":"Z"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$65","v":"E.3.8"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,1)","v":1},"PI - Possible conflict of interest for PI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A6)))","v":"PI - Possible conflict of interest for PI"}]
["Annex 1: Clinical Trial Application Form",77,"Prisons - Change involving PI responsible for the study at the prison service",{"$f":"$A$35","v":"Z"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$48","v":"E.2.1"},{"$f":"$A$62","v":"E.3.5"},{"$f":"$A$89","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,IF(AND('Amendment Tool'!$AE$74=1,'Amendment Tool'!$AF$74=1),1,0))","v":0},0,{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A7)))","v":{"$error":"#NUM!"}}]
["Annex 2: Notification of Amendment",84,"Prisons - Changes to the research team at the prison service (other than CIs or PIs)",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5),0,IF(AND('Amendment Tool'!$AE$74=1,'Amendment Tool'!$AF$74=1),1,0))","v":0},0,{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A8)))","v":{"$error":"#NUM!"}}]
["Completed Amendment Tool",0]
["Confirmation of any other Regulatory Approvals (e.g. CAG) and all correspondence",20,"Stop_or_Restart_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Confirmation of Clinical Trial Authorisation from MHRA and relevant correspondence",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$117:$Z$124,1)","v":5},null,"Stop_or_Restart_5/6"]
["Contract/Study Agreement template",45,"Other - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z117>0,$C117,0)","v":"Other - Please specify in the free text below"},{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A1)))","v":"Other - Please specify in the free text below"}]
["Copies of materials calling attention of potential participants to the research",61,"Permanent closure or withdrawal of a non-interventional study",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"IF($Z$119=1,0,1)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A2)))","v":"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant"}]
["Covering letter on headed paper",168,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$42","v":"C"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(OR('Amendment Tool'!$AF$60=1,'Amendment Tool'!$AF$64=1),1,0)","v":1},"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A3)))","v":"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant"}]
["Cover Letter",164,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant",{"$f":"$A$31","v":"Y"},"Y","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(OR('Amendment Tool'!$AF$60=1,'Amendment Tool'!$AF$64=1),1,0)","v":1},"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A4)))","v":"Restart of study following a temporary halt"}]
["Data Safety Monitoring Committee Charter",43,"Restart of study following a temporary halt",{"$f":"$A$31","v":"Y"},"Y","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$54","v":"E.2.7"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Restart of study following a temporary halt",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A5)))","v":"Temporary halt of CTIMP"}]
["Details of any Data Monitoring Committee",23,"Temporary halt of CTIMP",{"$f":"$A$31","v":"Y"},"Y","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$53","v":"E.2.6"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"Temporary halt of CTIMP",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A6)))","v":{"$error":"#NUM!"}}]
["Evidence of Sponsor insurance or indemnity (non NHS Sponsors only)",27,"Temporary halt of non-CTIMP",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},"N/A","N/A",{"$f":"IF($Z$122=1,0,1)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A7)))","v":{"$error":"#NUM!"}}]
["Financial Arrangements",43,"Temporary halt of non-CTIMP due to COVID-19",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$42","v":"C"},"N/A","N/A","N/A",{"$f":"IF($Z$122=1,0,1)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A8)))","v":{"$error":"#NUM!"}}]
["GP/consultant information sheets or letters",0]
["HRA Schedule of Events",17,"Study_Design_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["HRA Statement of Activities",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$128:$Z$144,1)","v":17},null,"Study_Design_17"]
["HTA License",70,"Background information - Change that affects scientific value of study",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},1,{"$f":"IF($Z128>0,$C128,0)","v":"Background information - Change that affects scientific value of study"},{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A1)))","v":"Background information - Change that affects scientific value of study"}]
["Instructions for use of medical device",192,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A2)))","v":"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)"}]
["Interview schedules or topic guides for participants",65,"Endpoint/objective - Change to the endpoint or the main objective",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},1,"Endpoint/objective - Change to the endpoint or the main objective",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A3)))","v":"Endpoint/objective - Change to the endpoint or the main objective"}]
["Investigator Brochure/SmPC",{"$f":"LEN(C131)","v":147},"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$33","v":"N"},"N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A4)))","v":"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["IRAS Application Form",155,"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below","N","N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A5)))","v":"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below"}]
["Laboratory Manual",98,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study","N","N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A6)))","v":"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study"}]
["Letter from funder",122,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A7)))","v":"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study"}]
["Letter from sponsor",58,"New arm - Addition of a study arm or placebo/control group",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"New arm - Addition of a study arm or placebo/control group",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A8)))","v":"New arm - Addition of a study arm or placebo/control group"}]
["Letter from statistician",163,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A9)))","v":"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"}]
["Letters of invitation to participant",154,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A10)))","v":"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["MHRA Notice of No Objection Letter (Medical Devices) and relevant correspondence",169,"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$42","v":"C"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A11)))","v":"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"}]
["Non-NHS/HSC Site Assessment Form",160,"Other significant change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Other significant change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A12)))","v":"Other significant change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Non-validated questionnaire",49,"Participant numbers - Minor change to sample size",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Participant numbers - Minor change to sample size",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A13)))","v":"Participant numbers - Minor change to sample size"}]
["Organisation Information Document",55,"Participant numbers - Significant change to sample size",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Participant numbers - Significant change to sample size",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A14)))","v":"Participant numbers - Significant change to sample size"}]
["Other",130,"Samples - addition of the storage or use of human tissue samples under the relevant legislation on Human Tissue for the first time",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Samples - addition of the storage or use of human tissue samples under the relevant legislation on Human Tissue for the first time",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A15)))","v":"Samples - addition of the storage or use of human tissue samples under the relevant legislation on Human Tissue for the first time"}]
["Participant consent form",97,"Samples - minor changes (e.g. to the logistical arrangements for transporting or storing samples)",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N","(Y)","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Samples - minor changes (e.g. to the logistical arrangements for transporting or storing samples)",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A16)))","v":"Samples - minor changes (e.g. to the logistical arrangements for transporting or storing samples)"}]
["Participant information sheet (PIS)",142,"Samples - significant changes (e.g. to the arrangements for removal, storage or use of samples under the relevant legislation on Human Tissue)",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N","(Y)","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Samples - significant changes (e.g. to the arrangements for removal, storage or use of samples under the relevant legislation on Human Tissue)",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A17)))","v":"Samples - significant changes (e.g. to the arrangements for removal, storage or use of samples under the relevant legislation on Human Tissue)"}]
["Pharmacy Manual",0]
["Pharmacy Single Technical Review Form",20,"Study_Documents_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Project Information - PDF",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$148:$Z$165,1)","v":17},null,"Study_Documents_11/12/17/18"]
["Proof of Insurance",34,"Correction of typographical errors",{"$f":"$A$33","v":"N"},"N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N",{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,{"$f":"IF($Z148>0,$C148,0)","v":"Correction of typographical errors"},{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A1)))","v":"Correction of typographical errors"}]
["Proof that data will be processed in compliance with union law on data protection",110,"CRF/other study data records - Changes in the documentation used by the research team for recording study data",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"CRF/other study data records - Changes in the documentation used by the research team for recording study data",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A2)))","v":"CRF/other study data records - Changes in the documentation used by the research team for recording study data"}]
["Recruitment Arrangements",45,"GDPR wording - Accepted wording used verbatim","N","N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"GDPR wording - Accepted wording used verbatim",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A3)))","v":"GDPR wording - Accepted wording used verbatim"}]
["Referee's report or other scientific critique report",50,"GDPR wording - Unaccepted alternative wording used","N","N",{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"GDPR wording - Unaccepted alternative wording used",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A4)))","v":"GDPR wording - Unaccepted alternative wording used"}]
["Research Exposure Form",59,"IB - Annual review (no changes except the last review date)","N","N",{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"IB - Annual review (no changes except the last review date)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A5)))","v":"IB - Annual review (no changes except the last review date)"}]
["Research protocol or project proposal",54,"IB - Changes to the reference safety information (RSI)",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},0,0,{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A6)))","v":"IB, SmPC - Non-substantial changes (e.g. that do not affect risk/benefit assessment)"}]
["Sample diary card/patient card",84,"IB, SmPC - Non-substantial changes (e.g. that do not affect risk/benefit assessment)","N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"IB, SmPC - Non-substantial changes (e.g. that do not affect risk/benefit assessment)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A7)))","v":"IB, SmPC - Substantial changes (e.g. affecting the risk/benefit assessment; changing Reference Safety Information)"}]
["Schedule of Events or SoECAT",114,"IB, SmPC - Substantial changes (e.g. affecting the risk/benefit assessment; changing Reference Safety Information)","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"IB, SmPC - Substantial changes (e.g. affecting the risk/benefit assessment; changing Reference Safety Information)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A8)))","v":"IMPD - Non-substantial changes"}]
["Study Design",30,"IMPD - Non-substantial changes","N",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"IMPD - Non-substantial changes",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A9)))","v":"IMPD - Substantial changes (including IMP labels, GMP documents, MIA (IMP), QP declarations)"}]
["Summary CV for Chief Investigator (CI)",92,"IMPD - Substantial changes (including IMP labels, GMP documents, MIA (IMP), QP declarations)","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$59","v":"E.3.2"},{"$f":"$A$88","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"IMPD - Substantial changes (including IMP labels, GMP documents, MIA (IMP), QP declarations)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A10)))","v":"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"}]
["Summary CV for student",232,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below","N",{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},"N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},"N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A11)))","v":"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Summary CV for supervisor (student research)",223,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below","N","N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A12)))","v":"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"}]
["Summary of any applicable exclusions to sponsor insurance (non-NHS sponsors only)",238,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$42","v":"C"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A13)))","v":"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Summary of product characteristics (SmPC)",229,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$31","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$64","v":"E.3.7"},{"$f":"$A$89","v":"Part 2"},1,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A14)))","v":"Post trial information for participants (which does not contradict the protocol)"}]
["Summary, synopsis or diagram (flowchart) of protocol in non technical language",80,"Post trial information for participants (which does not contradict the protocol)",{"$f":"$A$33","v":"N"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Post trial information for participants (which does not contradict the protocol)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A15)))","v":"Protocol - Non-substantial changes (e.g. not affecting safety or the scientific value of the trial)"}]
["Validated questionnaire",{"$f":"LEN(C163)","v":99},"Protocol - Non-substantial changes (e.g. not affecting safety or the scientific value of the trial)",{"$f":"$A$33","v":"N"},"N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Protocol - Non-substantial changes (e.g. not affecting safety or the scientific value of the trial)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A16)))","v":"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)"}]
[null,91,"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)",{"$f":"$A$31","v":"Y"},{"$f":"$A$31","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$49","v":"E.2.2"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$88","v":"Part 1"},1,"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A17)))","v":"Translations - Addition of translated versions of participant-facing documentation"}]
[null,82,"Translations - Addition of translated versions of participant-facing documentation",{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},"N","N","N",{"$f":"$A$33","v":"N"},{"$f":"$A$44","v":"N/A"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Translations - Addition of translated versions of participant-facing documentation",{"$f":"INDEX($AA$148:$AA$165,SMALL(IF(ISTEXT($AA$148:$AA$165),ROW($AA$1:$AA$18),\"\"),ROW(A18)))","v":{"$error":"#NUM!"}}]
[null,0]
[null,21,"Study_Management_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
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[null,31,"Contract/agreement arrangements",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},{"$f":"$A$32","v":"(Y)"},{"$f":"$A$33","v":"N"},{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1,'Amendment Tool'!$AF$109<=2),0,1)","v":1},{"$f":"IF($Z169>0,$C169,0)","v":"Contract/agreement arrangements"},{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A1)))","v":"Contract/agreement arrangements"}]
[null,22,"Equipment arrangements","N","N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},{"$f":"$Z$169","v":1},"Equipment arrangements",{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A2)))","v":"Equipment arrangements"}]
[null,92,"Funding arrangements - Changes that do not affect payments to participants/researchers/sites","N","N","Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$42","v":"C"},{"$f":"$A$55","v":"N/A"},{"$f":"$A$66","v":"N/A"},{"$f":"$A$87","v":"N/A"},1,"Funding arrangements - Changes that do not affect payments to participants/researchers/sites",{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A3)))","v":"Funding arrangements - Changes that do not affect payments to participants/researchers/sites"}]
[null,101,"Funding arrangements - Changes to the payments, benefits or incentives to be received by participants",{"$f":"$A$31","v":"Y"},{"$f":"$A$33","v":"N"},"Y","N","N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},"N","N","N",{"$f":"$A$32","v":"(Y)"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Funding arrangements - Changes to the payments, benefits or incentives to be received by participants",{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A4)))","v":"Funding arrangements - Changes to the payments, benefits or incentives to be received by participants"}]
[null,106,"Funding arrangements - Changes to the payments, benefits or incentives to be received by researchers/sites",{"$f":"$A$31","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$32","v":"(Y)"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$51","v":"E.2.4"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Funding arrangements - Changes to the payments, benefits or incentives to be received by researchers/sites",{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A5)))","v":"Funding arrangements - Changes to the payments, benefits or incentives to be received by researchers/sites"}]
[null,58,"Insurance - Changes to insurance or indemnity arrangements",{"$f":"$A$31","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"Y"},"N",{"$f":"$A$33","v":"N"},"N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},"N","N","N",{"$f":"$A$31","v":"Y"},{"$f":"$A$45","v":"V"},{"$f":"$A$50","v":"E.2.3"},{"$f":"$A$61","v":"E.3.4"},{"$f":"$A$89","v":"Part 2"},1,"Insurance - Changes to insurance or indemnity arrangements",{"$f":"INDEX($AA$169:$AA$181,SMALL(IF(ISTEXT($AA$169:$AA$181),ROW($AA$1:$AA$13),\"\"),ROW(A6)))","v":"Insurance - Changes to insurance or indemnity arrangements"}]
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["REC (MCA)",{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),0,IF(AND('Amendment Tool'!$AE$72=1,'Amendment Tool'!$AF$72=1),1,0))","v":0},{"$f":"IF($B$8=0,0,IF(OR('Amendment Tool'!$AJ$169:$AK$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$1013:$O$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$1013:$O$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$1013:$O$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D8:$F8=0),\"\",IF($C8=0,\"\",IF($D8>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D8:$F8=0),\"\",IF($C8=0,\"\",IF($D8>0,'Menu Data'!$A$33,IF($E8>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""},null,{"$f":"IF(AND('Amendment Tool'!$AJ$169:$AM$171=FALSE),\"\",IF('Amendment Tool'!$AH$120=0,\"\",IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5,K8='Menu Data'!$A$31),'Menu Data'!$A$25,IF(AND(L8='Menu Data'!$A$31,K8<>'Menu Data'!$A$31),'Menu Data'!$A$24,IF(OR(K8='Menu Data'!$A$31,Q8='Menu 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["CAG",{"$f":"IF(AND('Amendment Tool'!$AE$73=1,'Amendment Tool'!$AF$73=1),1,0)","v":0},{"$f":"IF($B$9=0,0,IF(OR('Amendment Tool'!$AJ$169:$AK$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$1013:$P$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$1013:$P$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$1013:$P$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D9:$F9=0),\"\",IF($C9=0,\"\",IF($D9>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D9:$F9=0),\"\",IF($C9=0,\"\",IF($D9>0,'Menu Data'!$A$33,IF($E9>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""}]
["HMPPS",{"$f":"IF(AND('Amendment Tool'!$AE$74=1,'Amendment Tool'!$AF$74=1),1,0)","v":0},{"$f":"IF($B$10=0,0,IF(OR('Amendment Tool'!$AJ$169:$AK$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$Q$1013:$Q$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$Q$1013:$Q$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$Q$1013:$Q$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D10:$F10=0),\"\",IF($C10=0,\"\",IF($D10>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D10:$F10=0),\"\",IF($C10=0,\"\",IF($D10>0,'Menu Data'!$A$33,IF($E10>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""}]
["HRA and HCRW Approval",{"$f":"IF(AND('Amendment Tool'!$AE$76=1,'Amendment Tool'!$AF$76=1),1,0)","v":1},{"$f":"IF(AND($B$11=1,(OR('Amendment Tool'!$AJ$169:$AK$169=TRUE,'Amendment Tool'!$AJ$225:$AK$225=TRUE,'Amendment Tool'!$AJ$281:$AK$281=TRUE,'Amendment Tool'!$AJ$337:$AK$337=TRUE,'Amendment Tool'!$AJ$393:$AK$393=TRUE,'Amendment Tool'!$AJ$449:$AK$449=TRUE,'Amendment Tool'!$AJ$505:$AK$505=TRUE,'Amendment Tool'!$AJ$561:$AK$561=TRUE,'Amendment Tool'!$AJ$617:$AK$617=TRUE,'Amendment Tool'!$AJ$673:$AK$673=TRUE))),1,0)","v":1},{"$f":"COUNTIF('Amendment Tool'!$R$1013:$R$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$R$1013:$R$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$R$1013:$R$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D11:$F11=0),\"\",IF($C11=0,\"\",IF($D11>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D11:$F11=0),\"\",IF($C11=0,\"\",IF($D11>0,'Menu Data'!$A$33,IF($E11>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""},null,{"$f":"'Amendment Tool'!C174","v":"Change 2"}]
["REC (AWIA)",{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),0,IF(AND('Amendment Tool'!$AE$72=1,'Amendment Tool'!$AF$72=1),1,0))","v":0},{"$f":"IF($B$12=0,0,IF(OR('Amendment Tool'!$AL$169:$AL$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$S$1013:$S$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$S$1013:$S$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$S$1013:$S$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D12:$F12=0),\"\",IF($C12=0,\"\",IF($D12>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D12:$F12=0),\"\",IF($C12=0,\"\",IF($D12>0,'Menu Data'!$A$33,IF($E12>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""},null,"Type","REC/MoDREC","MHRA Meds","MHRA Devs","ARSAC","Radiation","UKSW","REC (MCA)","CAG","HMPPS","HRA HCRW","REC (AWIA)","PBPP","SPS (RAEC)","NHS P","HSC REC","HSC DG","Prisons","HSC P","Category","Annex 2 Type","Annex 2 Reason","CWoW"]
["PBPP",{"$f":"IF(AND('Amendment Tool'!$AE$73=1,'Amendment Tool'!$AF$73=1),1,0)","v":0},{"$f":"IF($B$13=0,0,IF(OR('Amendment Tool'!$AL$169:$AL$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$T$1013:$T$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$T$1013:$T$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$T$1013:$T$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D13:$F13=0),\"\",IF($C13=0,\"\",IF($D13>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D13:$F13=0),\"\",IF($C13=0,\"\",IF($D13>0,'Menu Data'!$A$33,IF($E13>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""}]
["SPS (RAEC)",{"$f":"IF(AND('Amendment Tool'!$AE$74=1,'Amendment Tool'!$AF$74=1),1,0)","v":0},{"$f":"IF($B$14=0,0,IF(OR('Amendment Tool'!$AL$169:$AL$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$U$1013:$U$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$U$1013:$U$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$U$1013:$U$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D14:$F14=0),\"\",IF($C14=0,\"\",IF($D14>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D14:$F14=0),\"\",IF($C14=0,\"\",IF($D14>0,'Menu Data'!$A$33,IF($E14>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""}]
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["HSC REC",{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),0,IF(AND('Amendment Tool'!$AE$72=1,'Amendment Tool'!$AF$72=1),1,0))","v":0},{"$f":"IF($B$16=0,0,IF(OR('Amendment Tool'!$AM$169:$AM$675=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$W$1013:$W$1022,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$W$1013:$W$1022,'Menu Data'!$A$32)","v":0},{"$f":"COUNTIF('Amendment Tool'!$W$1013:$W$1022,'Menu Data'!$A$33)","v":0},{"$f":"IF(AND($D16:$F16=0),\"\",IF($C16=0,\"\",IF($D16>0,'Menu Data'!$A$31,'Menu Data'!$A$33)))","v":""},{"$f":"IF(AND($D16:$F16=0),\"\",IF($C16=0,\"\",IF($D16>0,'Menu Data'!$A$33,IF($E16>0,'Menu Data'!$A$31,'Menu Data'!$A$33))))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AH$6","v":"England/Wales"},{"$f":"$AI$6","v":"Scotland"},{"$f":"$AJ$6","v":"N. Ireland"},{"$f":"$AK$6","v":"England"},{"$f":"$AL$6","v":"Wales"},{"$f":"$AM$6","v":"Scotland"},{"$f":"$AN$6","v":"N. Ireland"},{"$f":"$AO$6","v":"England"},{"$f":"$AP$6","v":"Wales"},{"$f":"$AQ$6","v":"Scotland"},{"$f":"$AR$6","v":"N. Ireland"}]
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["Category",null,{"$f":"$C$7","v":1}]
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[]
["Area of Amendment","Based on amdt info selection","Applicable area list","Clean area list (array function)","Applicable area","Specific options area prefix","Specific options area target","Specific options area"]
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[{"$f":"'Menu Data'!$A3","v":"Confidential patient information arrangements "},{"$f":"IF(AND('Amendment Tool'!$AG$109=1,'Amendment Tool'!$AF$109<>4),0,IF(OR($B$9=1,$B$13=1,$B$17=1),1,0))","v":0},0,{"$f":"INDEX($C$31:$C$48,SMALL(IF(ISTEXT($C$31:$C$48),ROW($D$1:$D$18),\"\"),ROW(A2)))","v":"CTIMP IMP "},{"$f":"CONCATENATE(\"Area_\",$E$31)","v":"Area_11"},"Confidential_patient_information_arrangements_",{"$f":"'Menu Data'!$Z$11","v":9},"Confidential_patient_information_arrangements_9",null,"Type","REC/MoDREC","MHRA Meds","MHRA Devs","ARSAC","Radiation","UKSW","REC (MCA)","CAG","HMPPS","HRA HCRW","REC (AWIA)","PBPP","SPS (RAEC)","NHS P","HSC REC","HSC DG","Prisons","HSC P","Category","Annex 2 Type","Annex 2 Reason","CWoW"]
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[{"$f":"'Menu Data'!$A5","v":"CTIMP IMP "},{"$f":"IF(AND('Amendment Tool'!$AG$109=1,'Amendment Tool'!$AF$109<>4),0,IF($B$3=1,1,0))","v":1},"CTIMP IMP ",{"$f":"INDEX($C$31:$C$48,SMALL(IF(ISTEXT($C$31:$C$48),ROW($D$1:$D$18),\"\"),ROW(A4)))","v":"Other "},null,"CTIMP_IMP_",{"$f":"'Menu Data'!$Z$23","v":6},"CTIMP_IMP_6"]
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[]
[]
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[{"$f":"'Menu Data'!A27","v":"Non-substantial, no study-wide review required"},{"$f":"COUNTIF('Amendment Tool'!$AN$1013:$AN$1022,$A57)","v":0},0,{"$f":"INDEX($C$53:$C$58,SMALL(IF(ISTEXT($C$53:$C$58),ROW($C$1:$C$6),\"\"),ROW(A5)))","v":{"$error":"#NUM!"}},null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$2=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),2)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$3=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),3)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$4=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),4)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$5=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),5)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$6=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),6)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$7=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),7)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$8=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),8)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$9=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),9)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$10=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),10)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$11=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),11)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$12=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),12)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$13=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),13)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$14=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),14)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$15=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),15)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$16=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),16)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$17=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),17)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$18=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),18)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,'Menu Data'!$A$33,IF(Arrays!$C$19=0,'Menu Data'!$A$33,VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),19)))","v":"N"},{"$f":"IF('Amendment Tool'!M400=0,\"\",VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),20))","v":""},{"$f":"IF('Amendment Tool'!M400=0,\"\",IF(Arrays!$C$3=0,\"\",VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),21)))","v":""},{"$f":"IF('Amendment Tool'!M400=0,\"\",IF(Arrays!$C$3=0,\"\",VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),22)))","v":""},{"$f":"IF('Amendment Tool'!M400=0,\"\",IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1),VLOOKUP('Amendment Tool'!M400,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!M399,\" \",\"_\"),\"Full\")),23),\"\"))","v":""}]
[{"$f":"'Menu Data'!A28","v":"Non-notifiable"},{"$f":"COUNTIF('Amendment Tool'!$AN$1013:$AN$1022,$A58)","v":0},0,{"$f":"INDEX($C$53:$C$58,SMALL(IF(ISTEXT($C$53:$C$58),ROW($C$1:$C$6),\"\"),ROW(A6)))","v":{"$error":"#NUM!"}},null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AJ$449:$AM$451=FALSE),\"\",IF('Amendment Tool'!$M$400=0,\"\",IF(AND('Amendment Tool'!$AE$113=1,'Amendment Tool'!$AF$109=5,K58='Menu Data'!$A$31),'Menu Data'!$A$25,IF(AND(L58='Menu Data'!$A$31,K58<>'Menu Data'!$A$31),'Menu Data'!$A$24,IF(OR(K58='Menu Data'!$A$31,Q58='Menu Data'!$A$31,U58='Menu Data'!$A$31,Y58='Menu Data'!$A$31),$A$53,IF(AND(K58:L58='Menu Data'!$A$33,N58:P58='Menu Data'!$A$33),'Menu Data'!$A$28,IF(AND(K58:L58='Menu Data'!$A$33,N58:O58='Menu Data'!$A$33,P58<>'Menu Data'!$A$31),'Menu Data'!$A$27,'Menu Data'!$A$26)))))))","v":""},{"$f":"IF(AND('Amendment Tool'!$AJ$449:$AM$451=FALSE),'Menu Data'!$A$33,IF(K57='Menu Data'!$A$35,IF(AND(OR('Amendment Tool'!$AF$60=1,'Amendment 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Tool'!$AJ$449:$AM$451=FALSE),'Menu Data'!$A$33,IF(Q57='Menu Data'!$A$34,IF(AND(OR('Amendment Tool'!$AJ$449:$AK$451=TRUE),OR('Amendment Tool'!$AF$59=3,'Amendment Tool'!$AF$59=4)),'Menu Data'!$A$31,'Menu Data'!$A$33),Q57))","v":"N"},{"$f":"IF(R57='Menu Data'!$A$33,R57,IF(OR('Amendment Tool'!$AJ$449:$AK$451=TRUE),R57,'Menu Data'!$A$33))","v":"N"},{"$f":"IF(S57='Menu Data'!$A$33,S57,IF(OR('Amendment Tool'!$AJ$449:$AK$451=TRUE),S57,'Menu Data'!$A$33))","v":"N"},{"$f":"IF(T57='Menu Data'!$A$33,T57,IF(T57='Menu Data'!$A$36,IF(OR(AND('Amendment Tool'!$AF$81=FALSE,'Amendment Tool'!$AF$82=TRUE,'Amendment Tool'!$AJ$449=TRUE),AND('Amendment Tool'!$AG$81=FALSE,'Amendment Tool'!$AG$82=TRUE,'Amendment Tool'!$AK$449=TRUE)),'Menu Data'!$A$31,'Menu Data'!$A$32),IF(OR('Amendment Tool'!$AJ$449:$AK$449=TRUE),T57,'Menu Data'!$A$33)))","v":"N"},{"$f":"IF(AND('Amendment Tool'!$AJ$449:$AM$451=FALSE),'Menu Data'!$A$33,IF(U57='Menu Data'!$A$34,IF(AND(OR('Amendment Tool'!$AL$449:$AL$451=TRUE),OR('Amendment 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Data'!$A$33,AB57,IF(AB57='Menu Data'!$A$36,IF(AND('Amendment Tool'!$AI$81=FALSE,'Amendment Tool'!$AI$82=TRUE,'Amendment Tool'!$AM$449=TRUE),'Menu Data'!$A$31,'Menu Data'!$A$32),IF('Amendment Tool'!$AM$449=TRUE,AB57,'Menu Data'!$A$33)))","v":"N"},{"$f":"IF(Arrays!$C$20=0,\"\",IF(AC57=\"\",\"\",IF(AND('Amendment Tool'!AJ449:AM449=FALSE),'Menu Data'!$A$44,IF(AC57<>'Menu Data'!$A$45,AC57,IF('Amendment Tool'!AH450=1,'Menu Data'!$A$39,'Menu Data'!$A$41)))))","v":""},{"$f":"AD57","v":""},{"$f":"AE57","v":""},{"$f":"AF57","v":""},null,{"$f":"IF(AND(AC58='Menu Data'!$A$43)*OR(T58='Menu Data'!$A$31:$A$32),1,0)","v":0},{"$f":"IF(AND(AC58='Menu Data'!$A$43)*OR(X58='Menu Data'!$A$31:$A$32),1,0)","v":0},{"$f":"IF(AND(AC58='Menu Data'!$A$43)*OR(AB58='Menu Data'!$A$31:$A$32),1,0)","v":0},{"$f":"IF(AND('Amendment Tool'!$M$400='Menu Data'!$C$71)*OR('Amendment Tool'!AJ449=TRUE,'Amendment Tool'!AJ451=TRUE),1,0)","v":0},{"$f":"IF(AND('Amendment Tool'!$M$400='Menu Data'!$C$71)*OR('Amendment 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Data'!$C$8,'Amendment Tool'!$M400='Menu Data'!$C$107),1,0)","v":0}]
[]
["Document type","Based on amdt info selection","Applicable document types","Clean list of types (array function)","Applicable area"]
[{"$f":"'Menu Data'!A112","v":"Annex 1: Clinical Trial Application Form"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},{"$f":"IF($B61>0,$A61,0)","v":"Annex 1: Clinical Trial Application Form"},{"$f":"INDEX($C$61:$C$112,SMALL(IF(ISTEXT($C$61:$C$112),ROW($C$1:$C$52),\"\"),ROW(A1)))","v":"Annex 1: Clinical Trial Application Form"},{"$f":"COUNTIF($D$61:$D$112,\"*\")","v":48},null,null,null,null,{"$f":"'Amendment Tool'!C454","v":"Change 7"}]
[{"$f":"'Menu Data'!A113","v":"Annex 2: Notification of Amendment"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":1},"Annex 2: Notification of Amendment",{"$f":"INDEX($C$61:$C$112,SMALL(IF(ISTEXT($C$61:$C$112),ROW($C$1:$C$52),\"\"),ROW(A2)))","v":"Annex 2: Notification of Amendment"},{"$f":"CONCATENATE(\"Docs_\",$E$61)","v":"Docs_48"},null,null,null,null,"Type","REC/MoDREC","MHRA Meds","MHRA Devs","ARSAC","Radiation","UKSW","REC (MCA)","CAG","HMPPS","HRA HCRW","REC (AWIA)","PBPP","SPS (RAEC)","NHS P","HSC REC","HSC DG","Prisons","HSC P","Category","Annex 2 Type","Annex 2 Reason","CWoW"]
[{"$f":"'Menu Data'!A114","v":"Completed Amendment Tool"},1,"Completed Amendment Tool",{"$f":"INDEX($C$61:$C$112,SMALL(IF(ISTEXT($C$61:$C$112),ROW($C$1:$C$52),\"\"),ROW(A3)))","v":"Completed Amendment Tool"}]
[{"$f":"'Menu Data'!A115","v":"Confirmation of any other Regulatory Approvals (e.g. CAG) and all correspondence"},1,"Confirmation of any other Regulatory Approvals (e.g. CAG) and all correspondence",{"$f":"INDEX($C$61:$C$112,SMALL(IF(ISTEXT($C$61:$C$112),ROW($C$1:$C$52),\"\"),ROW(A4)))","v":"Confirmation of any other Regulatory Approvals (e.g. CAG) and all correspondence"}]
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