Since Monday 14 October 2024, and as part of work to speed up commercial research set up in the UK, the National Contract Value Review (NCVR) has been applied to more studies.
The NCVR is a standardised, national approach to costing for commercial contract research.
What has changed?
Clinical trials of investigational advanced therapy medicinal products (ATMPs) and Phase I and IIa clinical trials have been brought under NCVR since Monday 14 October 2024.
Advanced Therapy Medicinal Products model Clinical Trial Agreements
To support this change, a new model clinical trial agreement for investigational advanced therapy medicinal products (ATMP-mCTA), and a new clinical research organisation model clinical trial agreement for investigational advanced therapy medicinal products (CRO-ATMP-mCTA) have been introduced.
Both of these ATMP agreements include an unmodifiable financial appendix to support the inclusion of ATMP clinical trials in the National Contract Value Review process from the 14th of October 2024.
The new templates have been developed by the Four Nations Contracts Leads, which consists of representatives from the HRA and the Devolved Administrations of Northern Ireland, Scotland and Wales.
The new templates are now available on the IRAS website.
What does this mean?
From Monday 14 October 2024 the NCVR applies to ATMP clinical trials and Phase I and IIa clinical trials. This means:
- ATMP clinical trials now have new template agreements designed for them, which should be used without modification* for all phases of ATMP clinical trials.
- The model clinical trial agreement (mCTA), Contract Research Organisation (CRO) model clinical trial agreement (CRO-mCTA) and Primary Care model clinical trial agreement (PC-mCTA) should continue to be used without modification* for all other Phase I and IIa clinical trials in the NHS/HSC.
- The inclusion of ATMP and Phase I and IIa clinical trials in the NCVR means that from the 14 October 2024 the financial schedule generated from the interactive Costing Tool (iCT) should be inserted into the finance appendix of the relevant model agreement and agreed without local negotiation.
What does this mean for sites currently in set up from 14 October 2024?
Any agreement, for a Phase I, IIa or ATMP clinical trial in the HSC/NHS, not exchanged (signed by both parties and notified or returned to the sponsor) before the 14 October 2024 will need to follow the NCVR processes.
This means that any ATMP studies in set up in the HSC/NHS, with unsigned contracts from the 14 October 2024 onwards, will need to use the new contract template, with the UK-wide financial appendix and iCT generated finance schedule.
For HSC/NHS sites where contract exchange had not happened before 14 October 2024, the iCT generated budget will apply without local negotiation.
Feedback
Questions and/or feedback from HSC organisations on these agreements and their use should be provided to HSC Innovations at ResearchContracts@innovations.hscni.net, whereby these will be raised directly with the “Four Nations Contracts Leads”.
Assistance
For assistance with queries relating to model template agreements, contract drafting and negotiation for clinical trials or collaboration projects in research development and innovation, please contact ResearchContracts@innovations.hscni.net.
* Applicants are strongly 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.