IMPORTANT: Clinical Trials of Investigational Medicinal Products (CTIMPs) and Combined trials of an investigational medicinal product and an investigational medical device (IMP/Device trials).
If you are completing a new application for either a CTIMP or IMP/Device trial using the combined review service via the new part of IRAS please be aware that any reference in the text below to Part C of the IRAS form relates to Section G of the Medicines Information question set in your combined review application. Similarly, any reference to an ‘IRAS form’ refers to the study information PDF generated once you have submitted your combined review application.
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Please refer to the relevant section for guidance about the site level information you may need to provide for your research:
- NHS/HSC organisations participating in research (NHS/HSC research sites) – the 'UK Local Information Pack' is used to set up NHS/HSC participating organisations. Note: From 5 June 2019 NHS/HSC site specific information (SSI) forms are no longer used or accepted.
- Non-NHS/HSC organisations participating in research (non-NHS/HSC research sites) - the process for setting up non-NHS/HSC sites depends on the study type. Note: From 5 June 2019 Non-NHS/HSC Site Specific Information (SSI) Forms are no longer used or accepted
This page also provides information about:
- Participant Identification Centres (PICs) - NHS/HSC organisations that identify potential research participants for a research study (e.g. through search of patient databases) and have no other involvement in the research are referred to as PICs. Note PICs are not research sites and are not set up in the same way as research sites. further guidance is provided below.
- ARSAC Research Certificate Application (RCA) Forms - these forms are no longer used; please refer to information below.
On 5 June 2019, the ‘UK Local Information Pack’ fully implemented as the UK-wide mechanism for setting up participating NHS/HSC organisations. It provides a consistent package to support study set-up and delivery across the UK and should be used for all studies with participating NHS/HSC organisations from this date. An exception is where a study is planned as a single centre study with an NHS/HSC Sponsor (i.e. there is a single participating NHS/HSC organisation and it is the same as the NHS/HSC Sponsor for the study). In this specific scenario a UK Local Information Pack and Organisation Information Document is not required.
A key component of the UK Local Information Pack for non-commercially sponsored studies is the
‘Organisation Information Document’. This replaces the ‘Statements of Activities’ that were used in England and Wales for non-commercial studies, and the NHS/HSC Site Specific Information (SSI) Form that were used in Northern Ireland and Scotland. The Organisation Information Document is used for non-commercially sponsored research in the NHS/HSC. Note: the Organisation Information Document is not designed for use with participating non-NHS organisations – please refer to separate
guidance for non-NHS.
Sections in this guidance:
The Organisation Information Document is a key component of the UK Local Information Pack for non-commercial research projects.
There are different templates for the Organisation Information Document. You should use the appropriate template to create the ‘outline Organisation Information Document(s)’ for the project:
- Organisation Information Document for non-commercially sponsored projects – template and guidance
- Organisation Information Document for data processing only (non-commercially sponsored projects) – template.
Note that this document is intended for use as the data processing agreement between sponsor and participating NHS / HSC organisation where neither a national template agreement or Organisation Information Document are appropriate (i.e. for use between University Sponsor and Participating NHS / HSC organisation, which share a Joint Research Office and hence do not need to use the Local Information Pack to set up their ‘own’ organisation, for studies that are not clinical trials or clinical investigations).
The outline Organisation Information Document should give information that will be common to all participating NHS/HSC organisations that are undertaking the same activities within the study. In some studies, some NHS/HSC organisations will undertake different activities to others. In this scenario you will need to create and submit an outline Organisation Information Document for each group of NHS/HSC organisation undertaking the same activities.
The outline Organisation Information Document(s) must be electronically submitted as part of the IRAS Form application. This means you must attach the outline Organisation Information Document(s) to the IRAS Form checklist prior to e-submission of the application.
All new IRAS submissions should include the March 2024 version of the appropriate outline Organisation Information Document. However, previous versions will continue to be accepted until October 2024.
IMPORTANT: The Organisation Information Document should be localised before sharing with participating NHS/HSC organisations. This is referred to as the ‘localised Organisation Information Document’. Note: there are some circumstances where the Organisation Information Document may be shared with participating NHS/HSC organisations without first being localised (e.g. for low risk studies when sharing the document with a large number of potential participating NHS / HSC organisations). For more information please refer to the guidance for Organisation Information Document templates. Note that there are different mechanisms for sharing the localised Organisation Information Document (and UK Local Information Pack) with participating NHS/HSC organisations across the four nations. Please refer to the section on ‘Sharing the UK Local Information Pack’ for more information.
Commercially sponsored studies do not need to complete an Organisation Information Document. Instead they should include the relevant
commercial contract(s) / agreement(s). This means that this document must be attached to the IRAS Form checklist prior to e-submission.
A Schedule of Events or a SoECAT is required for all non-commercial studies, where a UK Local Information Pack is required. This will help to ensure that the appropriate resources are identified to support study delivery and that there is clarity for participating NHS/HSC organisations about how the costs associated with participating in a study are attributed.
If a
SoECAT has been completed as part of a funding application, then you should supply the SoECAT. You will need to provide one SoECAT per outline Organisation Information Document. If any of the details have changed during the funding process these should be reflected in the SoECAT submitted with the IRAS Form. The SoECAT will have to be reauthorized by an AcoRD specialist.
Where using the
UK Schedule of Events template (excel file), one Schedule of Events should be completed and submitted per outline Organisation Information Document submitted, i.e. if two outline Organisation information Documents are submitted, two IRAS Schedules of Events should be submitted, each completed for the site-level activities relevant to the accompanying outline Organisation Information Document (please see the non-commercial Organisation Information Document guidance). Further guidance on use of the Schedule of Events is provided as part of the template.
The Schedule of Events or a SoECAT (whichever is used) must be electronically submitted as part of the IRAS Form application. This means you must attach the file to the IRAS Form checklist prior to e-submission of the IRAS Form.
A delegation log held at the participating NHS/HSC organisation is appropriate for studies that are clinical trials (defined as first four categories in IRAS Project Filter question 2) where the local study activities are managed by a Principal Investigator (PI).
The delegation log provides clarity regarding who is responsible for undertaking what activity during delivery of the study. The delegation log is a tool to be maintained throughout the life time of the study at that participating organisation.
Sponsors may share the template delegation log that will be used in the study as part of sharing the UK Local Information Pack, or they may indicate in the email template used to share the UK Local Information Pack that they will share the delegation log template at a later date (e.g. after a site initiation visit). Where used and shared, the delegation log should include known research team names but not signatures (signatures should be put in place during site set up).
Sponsors can use the
UK template delegation log or may use their own delegation log templates if preferred.
In summary the UK Local Information Pack is made up of:
- Covering email using standard template format.
You will need to use the appropriate email template – please refer to the instructions below for sharing the Local Information Pack
- Localised Organisation Information Document (non-commercial studies).
The outline Organisation Information Document(s) submitted with the IRAS Form application must be localised before sharing with participating NHS/HSC Organisations. Refer to the previous section and the guidance provided with the templates for more information.
- UK Statement of Events / Schedule of Events Cost Attribution Tool (SoECAT)
The Schedule of Events or SoECAT forms part of the UK Local Information Pack for non-commercial studies only.
- Relevant contract (commercial studies)
In commercially sponsored studies the relevant model contract(s) / agreement(s) form part of the UK Local Information Pack.
- Delegation Log.
A delegation log is appropriate for studies that are clinical trials (defined as first four categories in IRAS Project Filter question 2) where the local study activities are managed by a Principal Investigator (PI). Sponsors may share the template delegation log that will be used in the study as part of sharing the UK Local Information Pack, or they may indicate in the email template used to share the UK Local Information Pack that they will share the delegation log template at a later date (e.g. after a site initiation visit). Where used and shared, the delegation log should include known research team names but not signatures (signatures should be put in place during site set up).
- Relevant supporting documents.
These will include some of the documents that have been submitted/approved with the IRAS Form submission and other documents to support study set up at the participating NHS/HSC organisation(s). Information about the documents to include is provided alongside the covering email templates provided.
The Sponsor, or authorised delegate, is responsible for sharing the UK Local Information Pack with participating NHS/HSC organisations; the process for doing this depends on where the NHS/HSC participating organisation is located – see next section.
The Sponsor, or authorised delegate, is responsible for sharing the UK Local Information Pack with participating NHS/HSC organisations and controls when this occurs. The process for sharing the UK Local Information Pack with participating NHS/HSC organisations is dependent upon the location of the participating organisations. Please refer to the guidance below. Where the study has participating NHS/HSC organisations in different nations you should refer to the instructions for all relevant nations.
Notes:
- Where the study has an NHS/HSC Sponsor, and the Sponsor and the participating NHS/HSC organisation are the same, there is no need for the NHS/HSC Sponsor to share the UK Local Information Pack with itself.
- Where an NHS organisation in England, Scotland or Wales works closely with a partner Higher Education Institution (HEI) in a Joint Research Office or similar arrangement, the NHS organisation may choose to treat single centred studies sponsored by their partner HEI in the same way as those studies sponsored by that NHS organisation.
Where the HEI is the Sponsor a study specific data processing agreement will need to be in place between the Sponsor and the NHS organisation to fulfil the requirements of GDPR. A simplified Organisation Information Document will be available which can be used as an agreement for GDPR purposes. Each national coordinating function will maintain a list of NHS organisations that choose to work under these arrangements with specific HEIs (this so they can be clear when to request Organisation Information Documents). The decision to work on this way rests with the NHS organisations. If unsure of local arrangements please discuss with your HEI/NHS Sponsor team.
Participating NHS organisations in England and Wales
The Sponsor localises the Organisation Information Document(s)(non-commercially sponsored studies) and emails it together with the other documents that make up the
UK Local Information Pack to the R&D office and study delivery team (Principal Investigator or Local Collaborator, as applicable) at participating NHS organisation(s).
If the study is an NIHR portfolio study, the Sponsor should copy the Local Information Pack to the LCRN of participating organisations in England.
This should take place after the Sponsor receives the Initial Assessment Letter or the Approval Letter from HRA/HCRW.
IMPORTANT: The Sponsor is expected to use the correct email template when sharing the UK Local Information Pack with participating NHS organisations in England and/or Wales:
Participating HSC organisations in Northern Ireland
The Sponsor localises the Organisation Information Document(s)(non-commercially sponsored studies) and emails it together with the other documents that make up the
UK Local Information Pack to the R&D office and study delivery team (Principal Investigator or Local Collaborator, as applicable) at participating HSC organisation(s).
IMPORTANT: The Sponsor is expected to use the correct email template when sharing the UK Local Information Pack with participating HSC organisations in Northern Ireland:
Participating NHS organisations in Scotland
The Sponsor localises the Organisation Information Document(s)(non-commercially sponsored studies) and emails it, along with the relevant delegation log for the site (if applicable), to
NRS Permissions Coordinating Centre (NRS Permissions CC) who will then make the Local Information Pack available to participating NHS organisations in Scotland (R&D, research teams and networks, as applicable). There is no need to supply documents already electronically submitted as part of the IRAS Form application as they will be made available to participating NHS sites in Scotland via NRS Permissions CC.
The Sponsor should email the localised Organisation Information Document(s) after the IRAS Form submission is validated. If there is more than one localised Organisation Information Document, then they should be sent via a single email to NRS Permissions CC or as available.
IMPORTANT: The Sponsor is expected to use the following template when sending the localised Organisation Information Document to NRS Permissions CC:
This section applies to projects with participating NHS/HSC organisations that are either preparing:
- For initial submission of the IRAS Form and/or set up of NHS/HSC sites; or
- To add new participating NHS/HSC organisations for a project that is already in progress
The UK Local Information Pack will be used for
all participating NHS/HSC organisations in England, Northern Ireland, Scotland and Wales.
This means that from 5 June 2019:
- NHS/HSC Site Specific Information (SSI) Forms will not be accepted for participating NHS/HSC organisations in Scotland or in Northern Ireland.
Note: NHS SSI forms were withdrawn from use in England and Wales prior to this date.
NHS/HSC SSI forms submitted prior to 5 June 2019 will be accepted and processed.
- Statement of Activity documents will not be accepted for participating NHS organisations in England and Wales.
Statements of Activities submitted prior to 5 June 2019 will be accepted and processed.
IRAS Form application in progress and participating NHS/HSC organisations being set up after 5 June 2019:
In this situation you should prepare to use the UK Local Information Pack for participating NHS/HSC organisations. This will mean that you will need to use Organisation Information Document(s) and not NHS/HSC SSI forms or Statements of Activities for participating NHS/HSC organisations.
If you have already created NHS/HSC SSIs (Scotland and Northern Ireland) and/or Statements of Activities (England/Wales) then you should cease work on these and changeover to preparing the Organisation Information Document and the UK Local Information Pack.
Setting up new NHS/HSC organisations to projects that previously used NHS/HSC SSI forms and/or Statements of Activities
If you are setting up new NHS/HSC organisations from 5 June 2019 in ongoing projects, then you should prepare to use the UK Local Information Pack for the new participating NHS/HSC organisations. This will mean that you will need to use Organisation Information Document(s) and not NHS/HSC SSI forms or Statements of Activities for the new participating NHS/HSC organisations. If these organisations were not listed in Part C of your original application, then you should follow the
amendment guidance for adding new NHS/HSC organisations.
If you have already created NHS/HSC SSIs (Scotland and Northern Ireland) and/or Statements of Activities (England/Wales) then you should cease work on these and changeover to preparing the Organisation Information Document and the UK Local Information Pack.
Please submit any feedback on your experience of using the UK Local Information Pack via the
survey.
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The guidance you need to follow depends on whether you are:
Including non-NHS/HSC site(s) as part of an initial application for ethical review
Clinical Trials of Investigational Medicinal Products (CTIMPs) and combination trials of an investigational medicinal product and an investigational medical device (IMP/Device)
If your trial is a CTIMP or IMP/Device trial, you need to use the new part of IRAS for combined review. There are instructions on how to upload documents for your application in the user guide.
To add non-NHS/HSC sites as part of your initial combined review application you should:
- list the sites in Section G of the “Medicines Information” question set
- complete and electronically submit a Non-NHS/HSC Site Assessment Form for each non-NHS/HSC site - the completed form should be electronically signed (this could be achieved by inserting an image of the signature; by printing out, signing and scanning the form; or by typing in name) and uploaded to the checklist associated with the initial/main application
- electronically submit the following documents with the main application, including:
- a short CV for the Principal Investigator(s)
- evidence of insurance or indemnity (not required for Phase 1 trials in healthy volunteers where the site is accredited by the MHRA)
- local versions of documentation (if they are significantly different to the main version)
Clinical Investigations of a Medical Device
If your trial is a clinical investigation of a medical device, you need to prepare your application using the standard part of IRAS. To include non-NHS/HSC sites as part of your initial application you should:
- list the sites in Part C of the application form for ethics review
- complete and electronically submit a Non-NHS/HSC Site Assessment Form for each non-NHS/HSC site – the completed form should be electronically signed (by inserting an image of the signature; by printing out, signing and scanning the form; or by typing in name) and uploaded to the checklist associated with the initial/main application for ethical review
- electronically submit several documents with the main application for ethics review:
- a short CV for the Principal Investigator(s)
- evidence of insurance or indemnity (not required for Phase 1 trials in healthy volunteers where the site is accredited by the MHRA)
- local versions of documentation (if they are significantly different to the main version)
When uploading your documents, you should ensure that the Non-NHS/HSC Site Assessment Form is uploaded to the row with this label. For additional supporting files (like a CV for Principal Investigator) use the "Add New Row" button at the end of the checklist.
If you're using the "IRAS Form" to apply for ethical review, a new section in the checklist labelled "Other" will be created for you to add your additional files.
However, if you’re using the “NHS REC Form” this will add a new row labelled “Other (please specify)” to the end of the checklist, and you’ll need to add a new row for each file that you add.
All other study types
For all other study types you need to make your application using the standard part of IRAS. You should list the sites in Part C of the application form for ethics review. You do not need to submit any additional forms or documents for non-NHS/HSC sites.
Adding a non-NHS/HSC site to an ongoing study
Adding a non-NHS/HSC site to a CTIMP, IMP/Device trial or a Clinical Investigation of a Medical Device
You should:
- complete the amendment tool, stating whether non-NHS/HSC sites are being added for the first time or if the study already involves non-NHS/HSC sites
- complete a Non-NHS/HSC Site Assessment Form for the non-NHS/HSC site and have it electronically signed (by inserting an image of the signature; by printing out, signing and scanning the form; or by typing in name) – if the amendment is to change the PI at an existing non-NHS site, then only questions 2 and 3 of the form need to be completed.
- follow the instructions on IRAS help for submitting your amendment ensuring you include the following documents in your submission:
- the completed amendment tool
- non-NHS/HSC Site Assessment Form
- short CV for the Principal Investigator(s)
- any other supporting documents for addition of new non-NHS/HSC site (for example evidence of insurance or indemnity (not required for Phase 1 trials in healthy volunteers where the site is accredited by the MHRA); local versions of documentation if they are significantly different to the main version)
Adding a non-NHS/HSC site for all other study types
You do not need to submit an amendment to the Research Ethics Committee or to notify them separately. No additional documentation or forms are needed for non-NHS/HSC sites in this case. The favourable ethics opinion will still apply to any additional sites.
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On 6 February 2018, the Administration of Radioactive Substances Advisory Committee (ARSAC) changed the way it grants approvals for research. As of this date, site specific ARSAC Research Certificate Applications (RCA) Forms are no longer used and therefore do not need to be completed in IRAS. The project level Preliminary Research Assessment (PRA) form is still used. Please refer to the
Administration of Radioactive Substances Advisory Committee (ARSAC) website for information on how and when to submit research applications to ARSAC, including what site level arrangements you will be expected to have in place.
Further guidance may also be sought from the
ARSAC Support Unit.
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Participant Identification Centres (PICs) are NHS/HSC organisations that identify potential research participants. They are not research sites and should not be treated in the same way as research sites.
What is a PIC?
An NHS/HSC organisation
is operating as a PIC when it:
- Identifies potential research participants by processing personal data (e.g. through carrying out a search of patient records database to identify individuals that meet a study’s eligibility criteria);
and
- Is following the sponsor(s) instructions in identifying potential research participants;
and
- Directs these potential participants elsewhere without undertaking any further research activity for that study (i.e. the research occurs at another legal entity).
However, an NHS/HSC organisation is
not a PIC when it is:
- Within the legal entity where the research that it is identifying potential research participants for it taking place (e.g. the NHS/HSC organisation is a hospital identifying potential participants to be referred to another hospital within the same NHS/HSC Trust or Health Board). In this instance the whole legal entity is treated as an investigator site or participating NHS/HSC organisation;
or
- Responsible for research activities, such as:
- Any protocol-specified assessment to determine whether the potential participant is eligible for the research study (e.g. a screening blood test or x-ray)
- The recruitment (informed consent) of participants into the research study
- The delivery of research procedures as specified in the research protocol.
or
- Identifying potential research participants through normal clinical activity (e.g. a routine clinic) and referring these individuals to a research study in order to gain access to clinical intervention(s).
or
- Advertising opportunities to participate in a specific study, e.g. via posters in waiting rooms.
How do I set up NHS/HSC PICs?
It is recommended that research sponsors:
- Consider the use of PICs at the study design/feasibility stage
- Approach relevant NHS/HSC organisations to discuss their in-principle support to act as a PIC
- Ensure appropriate contractual agreements are in place with the NHS/HSC PICs – see below
- All activities/ resource requirements proposed for PIC organisations must be detailed within the IRAS Form. You will need to answer YES to A73 to reveal the secondary PIC questions and include the contact details and activities of PICs associated with research sites (except where the activity is limited to displaying leaflets or posters only). Details of PICs should be entered in Part C of the form.
NHS/HSC PICs are not participating NHS/HSC organisations or research sites and so they cannot be set up through the UK Local Information Pack.
PIC activity for:
- NHS organisations in England and/or Wales - may only commence once HRA and HCRW Approval has been issued and the instructions regarding the necessity or otherwise of the organisation acting as a PIC and the research site to confirm their capacity and capability to take part has been followed, and there is an appropriate agreement in place with the NHS organisation acting as a PIC.
- HSC organisations in Northern Ireland - may only commence once capacity and capability has been confirmed by the research site and there is an appropriate agreement in place with the HSC organisation acting as a PIC.
- NHS organisations in Scotland - may only commence once NHS permission is granted by both the research site and the PIC site and there is an appropriate agreement in place with the NHS organisation acting as a PIC.
What will be reviewed by the PIC?
Organisations that are considering whether to act as an NHS/HSC PIC will primarily rely on the completed study-wide governance review (Scotland / Northern Ireland) and/or HRA and HCRW Approval (England / Wales) being in place. The organisation acting as a PIC will only consider the resource implications for the PIC.
What contracting arrangements should be put in place with NHS/HSC PICs?
NHS/HSC PICs should be set up by through a sub-contracting arrangement with the participating NHS/HSC organisation that the PIC supports. Appropriate data processing arrangements should be put in place by using the
appropriate model agreement.
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Page last updated: 22 March 2024