Help - Preparing & submitting applications - Templates for supporting documents
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Templates for supporting documents

Templates for supporting documents



Applications are normally accompanied by supporting documents. The package of supporting documents you will need to provide will depend on the type of application and the type of research activity that is planned. This page provides a guide to templates that are available and which may be useful as you are preparing your application. All templates apply UK-wide unless otherwise stated.



Consent forms and participant information



Advice on preparing the participant information sheet (PIS) and templates can be found at: http://www.hra-decisiontools.org.uk/consent/

Note: The Health Research Authority (HRA) on behalf of the UK has published General Data Protection Regulation (GDPR) transparency wording for inclusion in participant information sheets. This is available on the HRA website.

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Contracts and study agreements



Commercial Model Clinical Trial Agreements (mCTA and CRO-mCTA)

The January 2021 model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates should be used without modification for industry-sponsored clinical trials with NHS/HSC patients in hospitals throughout the UK Health Services.

These template model agreements are applicable to the health services in England, Northern Ireland, Scotland and Wales; they replace the 2020 versions. The accompanying Guidance Notes provide further background, an overview of the changes from the 2020 versions and more information on how and under which circumstances the templates should be used.

Research Sponsors (and CROs) are advised to familiarise themselves with the guidance before making first use of the January 2021 versions. NHS/HSC organisations, and particularly those responsible for negotiating mCTAs on their behalf, are advised to familiarise themselves and their organisational signatories with the revised mCTAs and ensure that they can implement them immediately.

Whilst March 2020 versions of these templates will still be accepted in IRAS submissions, for the time being, applicants are encouraged to adopt the 2021 versions at their earliest opportunity. Versions older than March 2020 will no longer be accepted in new IRAS submissions. Applicants are advised to use the templates without modification. Any proposed modifications will not be accepted unless first agreed by the UK Contracting Leads. Proposing modifications to the templates is likely to result in significant delay.

The guidance notes include contact points from where advice and assistance may be obtained.


Providing feedback

The UK Four Nations Contracting Leads Group meets regularly to review user feedback and consider future revisions. The ABPI has established mechanisms for obtaining feedback from Industry. Feedback from NHS/HSC organisations on the content of the templates and their use by Sponsors (and CROs) should be provided to mCTA@hra.nhs.uk.

Feedback received will be considered by the UK Contracting Leads group. The purpose of the group is both to ensure that the mCTAs are iterated as necessary to reflect changes in the regulatory and wider clinical research environment and also to ensure that lessons learned in practice are incorporated into guidance, training and other means of communication.



Commercial Primary Care Model Clinical Trial Agreements (PC-mCTA)

The January 2021 Primary Care model Clinical Trial Agreement (PC-mCTA) templates should be used without modification for industry-sponsored clinical trials with NHS/HSC patients in independent contractor general practices throughout the UK Health Services.

These template model agreements are applicable to the health services in England, Northern Ireland, Scotland and Wales; they replace the 2013 versions. The accompanying Guidance Notes provide further background, an overview of the changes from the 2013 versions and more information on how and under which circumstances the templates should be used. The bi-partite version is for use between research sponsor and general practice. The tri-partite version adds the general practitioner principal investigator as a party to the agreement. Sponsor, site and PI should agree between themselves which template is appropriate for the individual site.

Research Sponsors are advised to familiarise themselves with the guidance before making first use of the January 2021 versions. NHS/HSC independent contractor general practices, and particularly those responsible for negotiating mCTAs on their behalf, are advised to familiarise themselves and their organisational signatories with the revised PC-mCTAs and ensure that they can implement them immediately.

Whilst 2013 versions of these templates will still be accepted in IRAS submissions, for the time being, applicants are encouraged to adopt the 2021 versions at their earliest opportunity. Applicants are advised to use the templates without modification. Proposing modifications to the templates is likely to result in significant delay.

The guidance notes include contact points from where advice and assistance may be obtained.

Providing feedback

The UK Four Nations Contracting Leads Group meets regularly to review user feedback and consider future revisions. The ABPI has established mechanisms for obtaining feedback from Industry. Feedback from NHS/HSC organisations on the content of the templates and their use by Sponsors should be provided to mCTA@hra.nhs.uk.

Feedback received will be considered by the UK Contracting Leads group. The purpose of the group is both to ensure that the template agreements are iterated as necessary to reflect changes in the regulatory and wider clinical research environment and also to ensure that lessons learned in practice are incorporated into guidance, training and other means of communication.



UK-wide model Non-Commercial Agreement (mNCA)

The model Non-Commercial Agreement (mNCA) template is structured to meet the requirements of non-commercial sponsors and the NHS/HSC (or other) bodies undertaking the research. This agreement has been developed as a single UK-wide agreement template, meaning that it can be used irrespective of where the sponsor and research site are established. It is designed to be used without modification or negotiation.

The mNCA has been developed for a range of interventional research scenarios, including clinical trials, medical device studies, research using patient data and research using human tissue. The terms and conditions are suitable for all such scenarios and only completion of highlighted sections, including the schedules of the agreement, will differ depending on the study involved. Note: Where NHS sites are participating in non-commercial, non-interventional research in any UK nation it is expected that a non-commercial Organisation Information Document will be used as the agreement between sponsor and participating NHS/HSC organisation, in place of the mNCA.

The guidance notes include contact points from where advice and assistance may be obtained.


Providing feedback

Feedback and/or suggestions for updates to the mNCA and/or the guidance document should be sent to the contact points given in guidance document. Feedback received will be considered by the UK Four Nations Contracting Leads Group for potential future revisions.



Model agreements for Participant Identification Centres (mC-PICA and mNC-PICA)

Participant Identification Centres (PICs) are NHS/HSC organisations that identify potential research participants. 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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Other types of model agreement

Current templates for other types of model agreement are available at: http://www.ukcrc.org/regulation-governance/model-agreements/. It is recommended that model contracts or agreements are used unmodified. Where they are modified this should be highlighted.



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Costing Template



Across the UK, the use of the NIHR industry costing template has been agreed as the tool to facilitate swift negotiation of the costs between the sponsor and sites. It is therefore part of the supporting documentation pack for all commercial projects conducted in or through the NHS/HSC.

The NIHR industry costing template and associated guidance is provided at: https://www.nihr.ac.uk/partners-and-industry/industry/run-your-study-in-the-nhs/faster-costing-and-contracting.htm

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CV



Your CV needs to demonstrate that you are qualified by education, training and experience to conduct the research. A template and associated guidance has been produced, which is recommended by the Research Ethics Service and NHS/HSC. This is available via the Health Research Authority (HRA) website and is suitable for submission of CVs by:
  • Chief Investigators
  • Principal Investigators
  • Academic Supervisors


Note: you should refer to guidance and instructions to confirm when you need to provide CV(s).

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HR Good Practice Resource Pack



The HR Good Practice Resource Pack contains information and documentation to support the process for handling HR arrangements for researchers, and provides a streamlined approach for confirming details of the pre-engagement checks they have undergone with the NHS/HSC.

It applies to NHS/HSC organisations and Higher Education Institutions (HEIs) in England, Scotland, Wales and Northern Ireland, and has been developed in parallel with other arrangements across the UK to streamline the process for setting up research in NHS/HSC organisations.

Please refer to the IRAS Help page for the HR Good Practice Resource Pack.

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Protocol



The Health Research Authority has published protocol development tools for:

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Statements of Activities and Schedule of Events



IMPORTANT: On 5 June 2019, the UK Local Information Pack brought in some key changes to the process for setting up NHS/HSC participating organisations and the documentation provided.

Applicants should note that from this date:
  • the Statements of Activities template, which was used for non-commercial studies seeking HRA and HCRW Approval is replaced by the Organisation Information Document. The Organisation Information Document is used for commercial and non-commercial studies.
  • the UK Schedule of Events or SoECAT should be used for non-commercial studies.
Further guidance and templates for the Organisation Information Document and the UK Schedule of Events are provided in the IRAS Help section for the UK Local Information Pack.

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UK Local Information Pack - information about template documents needed for the pack



On 5 June 2019, the UK Local Information Pack brought in some key changes to the process for setting up NHS/HSC participating organisations and the documentation provided.

The UK Local Information Pack includes some documents that have UK-wide templates. These include: Organisation Information Document(s), UK Schedule of Events, and delegation log. The templates and guidance for these templates is provided in the IRAS Help section for the UK Local Information Pack.

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Page last updated: 24 May 2021



 
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