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 December 2023 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 of investigational medicinal products with NHS/HSC participants 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 October 2023 versions. The accompanying Guidance Notes provide further background, an overview of the changes from the October 2023 versions and more information on how and under which circumstances the templates should be used.

Research Sponsors (and CROs) should familiarise themselves with the guidance before making first use of the December 2023 versions. NHS/HSC organisations are advised to familiarise themselves and their organisational signatories with the revised mCTAs and ensure that they can implement them immediately. All parties should pay close attention to updates to the guidance and templates introduced from October 2023 which included the new unmodifiable financial appendix and finance schedule to align with the launch of stage 2 of the National Contract Value Review (NCVR) process.

All new IRAS submissions should use the December 2023 version of the appropriate agreement. However, the October 2023 version will continue to be accepted until June 2024. 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 alastair.nicholson@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 December 2023 Primary Care model Clinical Trial Agreement (PC-mCTA) templates should be used without modification for industry-sponsored clinical trials with NHS/HSC patients in NHS/HSC primary care independent contractors (for example 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 October 2023 versions. The accompanying Guidance Notes provide further background, an overview of the changes from the previous 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 the NHS/HSC primary care independent contractor trial site. The tri-partite version adds the principal investigator as a party to the agreement. Sponsor, trial 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 December 2023 versions. NHS/HSC primary care independent contractors, 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.  

All new IRAS submissions should use the December 2023 version of the appropriate agreement. However, the October 2023 version will continue to be accepted until June 2024. 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 should be provided to: 


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 December 2023 templates replace the October 2023 templates. NHS/HSC organisations are advised to familiarise themselves and their organisational signatories with the revised mCIAs and ensure that they can implement them immediately.

All new IRAS submissions should use the December 2023 version of the appropriate agreement. However, the October 2023 version will continue to be accepted until June 2024. It is expected that the templates are used without modification to ensure that all parties are compliant with requirements and expectations. Proposing modifications to the templates is likely to result in significant delay.

Templates:

Feedback on the content and use of these templates is encouraged as follows:

 

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Model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation mNISA (CRO-mNISA)

The model Non-Interventional Study Agreement (mNISA) and Clinical Research Organisation model Non-Interventional Study Agreement (CRO-mNISA) are designed to be used without modification for company-sponsored commercial non-interventional research with NHS research participants (including HSC research participants in Northern Ireland) throughout the UK Health Services.

The December 2023 templates replace the October 2023 versions.  

All new IRAS submissions should use the December 2023 version of the appropriate agreement. However, the October 2023 version will continue to be accepted until June 2024. It is expected that the templates are used without modification to ensure that all parties are compliant with requirements and expectations. Proposing modifications to the templates is likely to result in significant delay.  

Templates:

Feedback on the content and use of the templates is encouraged as follows:
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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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UK template Hub and Spoke Agreements

The UK template Hub and Spoke Agreements are for use between Lead Trial Sites (Trial Sites where a Principal Investigator is based) and Other Trial Sites (Trial Sites whose research activity is overseen by a Principal Investigator based at a Lead Trial Site), when a hub and spoke study delivery model is proposed. They are designed as subcontracts, passing down rights and responsibilities from the Lead Trial Site to the Other Trial Site, which itself is contracted to the sponsor through of one of the following unmodified model agreements:



It is expected that the hub and spoke templates are used without modification. Only then do they effectively pass down rights and responsibilities from the unmodified template agreement between sponsor and Lead Trial Site. Where a hub and spoke study delivery model is proposed, this should be described in the IRAS submission (where necessary, including details in the cover letter), or by subsequent amendment. The proposed hub and spoke agreement (as subcontract) and the unmodified model agreement (as contract) should be provided in the IRAS/amendment submission, as evidence that the sponsor intends to use the appropriate templates without modification. Further detail on use of Hub and Spoke arrangements may be found in the mNCA and mCTA/CRO-mCTA guidance documents (refer to links above) and in the guidance on set up of research activity at NHS organisations (interventional research).

All new IRAS submissions should use the December 2023 version of the appropriate agreement. However, the October 2023 version will continue to be accepted until June 2024.  It is expected that both the templates are used without modification to ensure that all parties are compliant with requirements and expectations. Proposing modifications to the templates is likely to result in significant delay.

Templates Hub and Spoke Agreements:


Queries and feedback

Queries and feedback about the Hub and Spoke agreements can be directed to the Contract Leads identified in the mNCA and mCTA/CRO-mCTA guidance documents (refer to links above).

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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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Model Material Transfer Agreement (mMTA)

The September 2021 mMTA should be used, without modification, by commercial or non-commercial research sponsors to contract NHS/HSC organisations in any UK nation, whose only role in a research study is the provision of human biological material to the sponsor or sponsor’s agent. mMTA is not intended for non-study-specific transfer of material between tissue collection centres and research tissue banks or biorepositories. Work is ongoing to develop a template suitable for these purposes.

Questions and/or feedback relating to the mMTA should be directed to: alastair.nicholson@hra.nhs.uk

The use of Material Transfer Agreements is common practice in research where Relevant Material (or other bodily material) is being transferred from an NHS organisation to be processed and stored by the receiving research site, tissue bank and/or sponsor, primarily for the purpose of answering the research question, or where it is intended to store or onward transfer the material for further research. Such agreements are not appropriate where the transfer is taking place primarily to determine the care pathway for a patient, including when this relates to determining the eligibility of a patient for an interventional research study, and not for future research. Transfers of material to help determine the research care pathway should be regarded as urgent and primarily for care purposes. NHS organisations requested to transfer material under such circumstances may take assurance from the letter of HRA and HCRW Approval (or equivalent study-wide review in Scotland or Northern Ireland) that such transfer has been considered appropriate. If there is any residual tissue after analysis for care pathways purposes is complete, this should be returned to sender promptly.

 

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Model Confidentiality Disclosure Agreements (mCDA and mMCDA) - for use during the early set-up of commercial contract research in NHS organisations

Confidentiality Disclosure Agreements (CDAs) (sometimes called non-disclosure agreements or NDAs) are legal agreements that are often used in commercial contract research to govern the sharing of confidential information from the commercial sponsor to the prospective participating NHS organisations prior to execution of the site agreement. For example mCTA, CRO-mCTA, mCIA, and so on.

This study specific CDA template and its associated guidance has been produced by a UK-wide partnership to help make the early sharing of information, for feasibility and site set-up purposes, clearer, more consistent, and efficient in line with the UK Vision for Clinical Research Delivery.

This recommended template is a resource Sponsors can choose to use with NHS sites. Doing so will reduce negotiation time with sites, provide assurances to both parties that their rights and responsibilities are appropriate and facilitate compliance by sites with contract terms, replacing the inconsistency of terms to which NHS organisations are currently subject.

The March 2023 version of the mCDA has been replaced with the April 2024 version. We strongly recommend that commercial sponsors and NHS organisations move to use the latest version of the agreement.

The mCDA and mMCDA are published as consultation in use therefore questions or feedback should be sent to the appropriate contracting lead, as follows:

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Other types of model agreement

Listed above are all of the model agreement that are currently available. 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: 10 May 2024



 
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