Help - Preparing & submitting applications - Site specific information
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Site specific information

Site specific information





IRAS has the functionality to create three types of site level information form. These are:
  • NHS/HSC Site Specific Information (SSI) Forms – these are currently used as part of the permission process for research involving the NHS/HSC in Scotland and Northern Ireland. These should be prepared and submitted in accordance with national arrangements - see relevant sections below.

    IMPORTANT: From 5 June 2019, the UK Local Information Pack will be introduced. This will bring in some key changes to the process for setting up NHS/HSC participating organisations and the documentation provided. From this date NHS/HSC SSI Forms will no longer be accepted. Please refer to the guidance for more information.

  • Non-NHS Site Specific Information Forms

    IMPORTANT: On 5 June 2019, Non-NHS/HSC Site Specific Information (SSI) Forms will be withdrawn from use. Clinical Trials of Investigational Medicinal Products (CTIMPs) and Clinical Investigations of Medical Devices with Non-NHS/HSC sites will use a new template form from this date.

  • ARSAC Research Certificate Application (RCA) Forms

This page also provides information about Participant Identification Centres (PICs).



NHS/HSC Site Specific Information (SSI) Form


IMPORTANT: From 5 June 2019, the UK Local Information Pack will be introduced. This will bring in some key changes to the process for setting up NHS/HSC participating organisations and the documentation provided. NHS/HSC SSI Forms will not be accepted from this date. Please refer to the guidance for more information.

The NHS/HSC Site-Specific Information (SSI) Form is currently used as part of the NHS/HSC permission process for research at NHS/HSC local research sites in Northern Ireland and Scotland.

The NHS/HSC SSI Form should only be completed after Parts A–D of the integrated dataset in IRAS have been completed because elements of the NHS/HSC SSI Form are populated by these sections of the integrated dataset.

The Chief Investigator (CI) should transfer the NHS/HSC SSI Form to the Principal Investigator (PI) or Local Investigator at the site for completion.

Guidance on how to apply to conduct research in NHS/HSC organisations is provided in the NHS/HSC R&D Permissions page of IRAS Help.

Guidance on the submission requirements for your NHS/HSC SSI Form is set out below. Please refer to the section that relates to the location of the participating NHS/HSC organisation.

Quick links:
England / Wales
Northern Ireland
Scotland
Cross-border arrangements for provision of NHS/HSC local site-specific information for cross-border studies
UK Local Information Pack




  • England and/or Wales

  • NHS SSI forms are not used for NHS research sites in England and/or Wales. Researchers wishing to conduct research in the NHS in England and/or Wales should refer to the separate guidance for site level information for participating NHS organisations in England and Wales under HRA and HCRW Approval.



  • Northern Ireland

  • For further guidance on seeking HSC R&D Permission for participating HSC organisations in Northern Ireland please refer to HSC website.



  • Scotland

  • For further guidance on seeking NHS R&D Permission for participating NHS organisations in Scotland please refer to the NHS Research Scotland website 



  • Cross-border arrangements for provision of NHS/HSC local site-specific information for cross-border studies

  • On 5 June 2019, the UK Local Information Pack will be introduced. This will bring in a UK-wide approach and mean some key changes to the process for setting up NHS/HSC participating organisations and the documentation that needs to be provided. Please refer to the guidance for more information.

    Participating NHS/HSC organisations being set up before 5 June 2019 should continue to use the interim position for the management of local NHS/HSC site information:
    • NHS/HSC Site Specific Information (SSI) Forms are used for setting up studies in Northern Ireland and Scotland.
    • Research studies led from England and/or Wales with research sites in Northern Ireland and/or Scotland should use NHS/HSC SSI Forms for the NHS/HSC sites in Northern Ireland and Scotland only.
    • NHS SSI Forms are not used for sites in England and Wales. Local information should be provided according to HRA and HCRW guidance
    • Research studies led from Northern Ireland or Scotland with NHS sites in England and/or Wales should provide local information in accordance with HRA and HCRW requirements. Sponsors (or authorised delegates) are advised to contact HRA or HCRW teams (please see linked page for contact information) at the earliest opportunity so that they can, for the English and/or Welsh NHS sites: facilitate the completion of information requirements; confirm with the sponsor that the information is correct; and facilitate the review of the research study for these sites.

    Participating NHS/HSC organisations being set up after 5 June 2019 will use the UK Local Information Pack and associated templates. Please refer to the guidance below.

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    UK Local Information Pack



    From 5 June 2019, the ‘UK Local Information Pack’ will be the UK-wide mechanism for setting up participating NHS/HSC organisations. It will provide a consistent package to support study set-up and delivery across the UK and will 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 is the ‘Organisation Information Document’ . This will replace the current Statements of Activities used in England and Wales for non-commercial studies, and the NHS/HSC Site Specific Information (SSI) Form used in Northern Ireland and Scotland. The Organisation Information Document will be used for both commercial and 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:


    Organisation Information Document


    The Organisation Information Document replaces:
    • the Statements of Activities, which have been used for non-commercial studies, in England and Wales; and
    • the NHS/HSC Site Specific Information (SSI) Form in Scotland and Northern Ireland.
    The Organisation Information Document will be a key component of the UK Local Information Pack for commercial and non-commercial research projects.

    There are different templates for the Organisation Information Document according to whether the study is a commercial or non-commercially sponsored project. You should use the appropriate template to create the ‘outline Organisation Information Document(s)’ for the project:
    • Organisation Information Document for commercially sponsored projects – template and guidance
    • 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.

    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’. Please refer to the guidance provided with the templates above. 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.



    Schedule of Events / Schedule of Events Cost Attribution Tool (SoECAT)


    A Schedule of Events or a SoECAT is required for all non-commercial studies. This will help to ensure that the appropriate resources are identified to support study delivery and 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. 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.

    The UK Schedule of Events template is provided here.



    Delegation Log


    A delegation log held at the participating NHS/HSC organisation is important for all studies where a principal investigator is required. It 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.

    The template delegation log should be supplied to the participating NHS/HSC organisation as part of the Local Information Pack.

    Sponsors can use the UK template delegation log or may use their own delegation log templates if preferred.



    Contents of the UK Local Information Pack


    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.
      There are different template Organisation Information Documents for commercial and 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.
    • Delegation Log.
      The delegation log should include known research team names but not signatures.
    • 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.


    Sharing the UK Local Information Pack with participating NHS/HSC organisations


    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) 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) 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) and emails it, along with the relevant delegation log for the site, 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:

    Studies in progress prior to 5 June 2019 – applications in progress or adding new NHS/HSC sites


    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 Packs will be used for all participating NHS/HSC organisations in England, Northern Ireland, Scotland and Wales.

    This means that from this date:
    • 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 before 5 June 2019:

    In this situation applicant should continue to use:
    • NHS/HSC SSI Forms for participating NHS/HSC organisations in Northern Ireland and Scotland
    • Statements of Activities for non-commercial studies with participating NHS organisations in England and Wales
    In this scenario, you must ensure that you have submitted the documentation to participating NHS/HSC organisations prior to the 5 June 2019. As noted above NHS/HSC SSI forms and Statements of Activities will not be accepted after this date.

    Note that you can prepare and submit outline Organisation Information Document(s) with your IRAS Form before 5 June 2019. However, the localised Organisation Information Document(s) and UK Local Information Pack(s) can only be shared with participating NHS/HSC organisations after this date.

    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.

    Note that you can prepare and submit outline Organisation Information Document(s) with your IRAS Form before 5 June 2019. However, the localised Organisation Information Document(s) and UK Local Information Pack(s) can only be shared with participating NHS/HSC organisations after this date.

    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.



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    Non-NHS Site Specific Information Form


    IMPORTANT: On 5 June 2019, Non-NHS/HSC Site Specific Information (SSI) Forms will be withdrawn from use. Clinical Trials of Investigational Medicinal Products (CTIMPs) and Clinical Investigations of Medical Devices with Non-NHS/HSC sites will use a new template form from this date.

    Site-specific assessment (SSA) is an assessment of the suitability of the local research site and investigator to conduct the research. SSA for non-NHS sites is only required as part of the ethical review for some types of research – refer to Section 5 of the UK Health Departments’ Research Ethics Service Standard Operating Procedures for more information and guidance on SSA procedures. For other types of research taking place at non-NHS sites, application for SSA is not required. All sites listed in the application to the REC, and any other sites added during the course of the study, will be deemed to be ethically approved as part of a favourable opinion from the REC. Management permission is still required from the organisation responsible for hosting the research before it commences at any site.

    Where SSA is required for non-NHS site(s), you will need to create non-NHS Site Specific Information (SSI) Form(s) and electronically submit the form and supporting documentation, as indicated on the Checklist tab. Please refer to the E-submission tab for the non-NHS SSI form for guidance and instructions on how to submit the application.

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    ARSAC Research Certificate Application (RCA) Forms



    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)



    What is a PIC?
    A PIC is where an organisation:
    • Identifies participants, largely (but not exclusively) through patient records, for possible participation in studies
    • Provides information about / or informs patients directly about a study, e.g. a clinician speaks directly to a patient
    • Advertises the opportunities to participate in a specific study, e.g. via posters in waiting rooms
    and
    • Where the research is taking place elsewhere.


    An organisation is not acting as a PIC when it is responsible for:
    • Any protocol-specified assessment to determine participant eligibility for a study, e.g. a screening blood test or x-ray
    • The recruitment (informed consent) of participants into a research study
    • The delivery of research procedures specified in the research protocol


    How do I apply?
    To enable NHS/HSC organisations to operate proportionate approaches to NHS/HSC permissions, researchers are recommended to:
    1. Consider the use of PICs at the study design/feasibility stage
    2. Approach relevant NHS/HSC organisations to discuss their in-principle support to act as a PIC
    3. 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.
    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.

    PIC activity for organisations in Northern Ireland and/or Scotland may only commence once NHS/HSC permission is granted by both the research site and the organisation acting as a PIC.

    What will be reviewed by the PIC?
    Organisations that are considering whether to act as a PIC will primarily rely on the completed study-wide governance review. The local governance review at the organisation acting as a PIC will only consider:
    • The resource implications for the PIC site
    • If the patient information is clear about who is hosting the research and who will provide compensation for clinical negligence


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    Page last updated: 21 May 2019



     
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