We are inviting comments, on a new draft commercial agreement financial appendix, from NHS organisations, commercial research sponsors and contract research organisations (CROs).
The newly drafted commercial agreement financial appendix has been developed in response to the government’s commitment to implement an ‘unmodifiable financial appendix that will remove local contract and contract-value negotiation from the NCVR process from 1 October 2023’.
We previously spoke about our intention to seek comments on this new document in a HRA Now sent on 22 June.
What is being proposed?
The new financial appendix will be mandated for unmodified use, for commercial contract clinical research studies within the scope of the National Contract Value Review (NCVR) programme, that are submitted for regulatory review via IRAS from 1 October 2023.
This aligns with implementation of stage two of NCVR from that date. It also aligns with existing expectations and requirements for unmodified use of UK model agreements, as set out for England in the National Directive on Commercial Contract Research and in equivalent policy positions in each of the devolved administrations.
Unmodified use of the financial appendix will be a condition of HRA and HCRW Approval, in England and Wales, and equivalent processes in Scotland and Northern Ireland, for NCVR studies submitted from this date.
In the list of documents below there is also a document containing tracked changed excerpts from mCTA, to explain the changes proposed to align the body of the agreement with the new appendix.
Documents to comment on
Below are the draft documents that we are inviting comment on:
- Template Financial Appendix
- Template Finance Schedule
- Proposed updates to the body of the mCTA template (please note you will need to download this document to view the track changes)
How will the new financial appendix be used?
The draft financial appendix is made up of two parts:
- The clauses will be incorporated into each of the UK model agreement templates for commercial contract research and modification will not be permitted, except as explicitly set out in each template. Please note that the version shared for comments has been drafted as a financial appendix specific to the model Clinical Trial Agreement (mCTA). When published, in each of the model commercial agreements, minor adjustments will be made to align clauses with the defined terms of each specific agreement and other template-specific matters (for example, the version published in CRO-mCTA will include references to CROs).
- The financial schedule will be generated by the sponsor, or party acting on its behalf, following the interactive Costing Tool (iCT) study resource review (conducted as part of NCVR, where applicable) and pasted into the financial appendix, prior to sharing the agreement with the site. For NCVR studies, modifications to the finance schedule will not be permitted by any party. The draft that is shared for comment has ‘dummy’ details pre-populating the finance schedule, for illustrative purposes.
Things to consider in your response
Please focus only on content that would cause a major issue for your company or organisation when the template becomes mandated for use from October. There will be further opportunities to comment and improve upon the template once published.
Please provide as much detail as possible for any additions, deletions or changes that you consider essential. Where possible, please provide evidence of the impact of the issue you are raising and focus on practical implications of not making the proposed change.
We will do our best to ensure that any major issues reported are addressed in the final published version.
How to share comments
NHS organisations across the UK, commercial research sponsors and CROs are invited to comment upon the detail of the proposed templates by email to mcta@hra.nhs.uk
Please ensure that only one response is submitted per organisation. Individuals with existing contract sign-off responsibilities for commercial contract research agreements are asked to co-ordinate responses on behalf of your organisation.
If you have detailed comments on specific sections of a document, please make your comments in the document and attach it to your email response. Any general comments can be shared in your email.
The deadline for responses is 9am on Monday 17 July 2023.