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 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, specifically:



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) 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 February 2018 revised model Clinical Trial Agreement (mCTA) and Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) templates are designed to be used without modification for industry-sponsored trials in NHS/HSC patients in hospitals throughout the UK Health Service.

These template model agreements are applicable to the health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 nation specific versions. The accompanying Guidance Notes provide further background, an overview of the changes from the 2011 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 February 2018 versions. NHS/HSC organisations, and particularly those responsible for negotiating mCTAs on their behalf, are advised to famailiarise themselves and their organisational signatories with the revised mCTAs and ensure that they can implement them immediately.

The guidance notes include contact points from where advice and assistance may be obtained.
Implementation of February 2018 versions

The Health Research Authority (HRA) in England and the Health Departments in the Devolved Administrations expect Sponsors (and CROs) to use the February 2018 mCTAs, without modification and in accordance with the guidance, when contracting with NHS/HSC organisations to deliver industry sponsored trials. Similarly, it is expected that NHS/HSC organisations will accept unmodified mCTAs without further review of the standard template elements.

Although the February 2018 mCTAs replace the 2011 versions, it is expected that both Sponsors (CROs) and NHS/HSC organisations exercise pragmatism in managing the transition. For example, we would not expect that any party to a contract negotiation already commenced on the basis of the 2011 version should propose use of the February 2018 version, where this would introduce delay in the contracting process. Even where a sponsor has yet to propose a contract template to a site, we would expect that sites demonstrate pragmatism in continuing to accept unmodified 2011 versions whilst sponsors (and CROs) finalise their internal change management processes to transition to use of the February 2018 version. Further guidance on this transition phase will be given following feedback from stakeholders.

Providing feedback

Alongside the launch of the February 2018 mCTAs, we are also establishing formal mechanisms for feedback. 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 on this form and sent to hra.mcta@nhs.net.

Feedback received will be considered by a group, comprising of representatives from Industry and the NHS/HSC. 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.



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 research scenarios, including clinical trials, medical device studies, research using patient data only 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 England or Wales it is expected that a Statement of Activities will be used 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: hra.mNCA@nhs.net

Feedback received will be considered by an oversight group that has been established. It is envisaged that the group will formally convene every six months in the longer term but may be consulted more frequently in the short term.



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/funding-and-support/study-support-service/early-contact-and-engagement/commercial-study-costing-templates.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


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Protocol

The Health Research Authority has published protocol development tools for:

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Statement of Activities and Schedule of Events

The HRA and Health and Care Research Wales (HCRW) Statement of Activities and Schedule of Events templates form part of the supporting documentation associated with the IRAS Form for all non-commercially sponsored studies with participating NHS sites in England and/or Wales. These templates are used to capture all information around study activities being undertaken at a local level. Please refer to the general and question specific guidance provided in the templates. Note that:
  • All questions in the template marked with a red asterisk indicate a sponsor/applicant field that should be completed before the document is submitted
  • If you project has more than one NHS research site and not all of these sites will be undertaking the same research activities (i.e. you have more than one 'site-type') then one Statement of Activities and one Schedule of Events should be submitted for each site-type, not for each site.
  • Completed Statement of Activities template(s) must be saved as a Word file and the filename should include the IRAS ID.
  • Completed Schedule of Events template(s) must be saved as an Excel file and the filename should include the IRAS ID.
The templates are available at: https://www.hra.nhs.uk/planning-and-improving-research/research-planning/prepare-study-documentation/

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Page last updated: 24 July 2018


 
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