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.

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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.

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Model Clinical Investigation Agreement (mCIA) and Clinical Research Organisation model Clinical Investigation Agreement (CRO-mCIA)

The model Clinical Investigation Agreement (mCIA) and Clinical Research Organisation model Clinical Investigation Agreement (CRO-mCIA) are designed to be used without modification for company-sponsored commercial research of medical devices in patients in hospitals throughout the UK Health Services.

The 2021 templates are UK wide, replacing the 2014 nation-specific templates. As well as providing UK-wide templates, the 2021 versions have been updated in light of regulatory and other changes.

Templates: The 2021 templates are published as consultation in use documents and feedback is encouraged as follows: Although these templates are currently published as consultation in use, it is strongly recommended that the appropriate template is used without modification, to ensure that all parties are compliant with requirements and expectations and to avoid potentially significant delays associated with negotiating proposed modifications.

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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.

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

Participant Identification Centres (PICs) are NHS/HSC organisations that identify potential research participants. In commercial contract research, NHS/HSC PICs should be set up by through a sub-contracting arrangement with the participating organisation that the PIC supports. In non-commercial research, the sponsor may choose to instruct their participating organisations to set up PICs through the equivalent non-commercial subcontract. Alternatively, a template is provided for use when the non-commercial sponsor chooses to directly contract its PICs. Use of the appropriate model agreement ensures that compliant data processing agreement terms are in place between the sponsor (site, as applicable) and PIC:

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Standalone Data Processing Agreements

In May 2018, the General Data Protection Regulation (GDPR) and The Data Protection Act 2018 created a new legal obligation on data Controllers to legally bind their processors by contract or other legally binding instrument (GDPR Article 28(3)). Accordingly, revised versions of the mNCA (2018) and mCTA (2020) were released, with the inclusion of GDPR Article 28(3) compliant data processing clauses. Unmodified use of these agreements helps to ensure that the sponsor complies with this specific data protection obligation, whilst similarly helping to ensure that all parties comply with their wider obligations. For non-interventional, non-commercial research, the organisation information document was released for use UK wide, containing equivalent data processing clauses when used as the study agreement.

In addition to these study specific template agreements, standalone data processing agreements have been drafted and are available for the discretionary use of both commercial and non-commercial research sponsors. The purpose of these two templates is to allow research sponsors to bring in line with GDPR Article 28(3) processing of personal data undertaken by their research sites as part of research projects contracted with older versions of the model templates (or with non-model templates) and which therefore did not include GDPR compliant data processing clauses. Each template is intended to form a legally binding contract in its own right, covering the data processing undertaken by the participating organisation on behalf of the sponsor for the studies listed in the appendix/schedule. Use of the template allows pre-existing studies to be brought in line without requiring variation to individual study agreements, as the data processing clauses apply to all named studies.

Use of the templates is entirely at sponsor discretion. As the GDPR Article 28(3) obligation falls on the sponsor, sites are advised not to actively seek stand-alone agreements from their sponsors but to work in a timely manner with sponsors who propose such agreements to them. Sponsors are advised not to propose modifications to the templates, as review of proposed modifications from multiple sponsors would place an unacceptable burden upon NHS R&D offices. R&D offices in receipt of modified or otherwise non-standard standalone data processing agreements are strongly encouraged to decline to sign whilst directing sponsors to this guidance.

Sponsors should complete one template per NHS organisation at which they have research for which personal data is being processed but for which a GDPR compliant data processing agreement is not already in place. The sponsor-signed and completed agreement should be provided to the R&D office of each NHS organisation for signature (by electronic or other means) and return of one executed copy to the sponsor. One executed copy should be held on file by the R&D office. Sponsors may choose to provide a non-exhaustive list of studies in the first instance (if, for example, their records allow them to more rapidly identify actively recruiting studies, or those in follow-up, than those where the only processing activity occurring at site is the storage of personal data for research purposes). The agreements may be updated, in accordance with their own modification clauses, to add additional studies later identified.


Questions or comments related to these templates and/or their use should be directed to the most appropriate national contracting lead, as follows:

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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 - Interactive Costing Tool (commercially sponsored studies)



Across the UK, the use of the NIHR interactive costing tool 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 interactive costing tool 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 UK Schedule of Events/SoECAT



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 non-commercial studies only.
  • 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/SoECAT 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: 22 October 2021



 
IRAS Integrated Research Application System, version 5.21, 14/09/2021, IRAS Dataset version 3.5.
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