 What: The NCVR will apply to ATMP clinical trials, and new ATMP-mCTAs templates published
Who: commercial sponsors, Contract Research Organisations (CRO) and participating NHS organisations
When: Monday 14 October 2024
What's changing
From Monday 14 October, as part of work to speed up commercial research set up in the UK, the National Contract Value Review (NCVR) will apply to more studies.
The NCVR is a standardised, national approach to costing for commercial contract research.
Clinical trials of investigational advanced therapy medicinal products (ATMPs) and Phase I and IIa clinical trials will be brought under NCVR from Monday 14 October.
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) are being introduced.
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, the NCVR will now apply 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.
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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.
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The inclusion of ATMP and Phase I and IIa clinical trials in the NCVR means that from the 14 October 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 NHS, not exchanged (signed by both parties and notified or returned to the sponsor) will need to follow the NCVR processes from 14 October 2024.
This means that any ATMP studies in set up in the NHS, with unsigned contracts on the 14 October 2024, will need to use the new contract template, with the UK-wide financial appendix and iCT generated finance schedule.
For NHS sites where contract exchange has not happened before 14 October 2024, the iCT generated budget will apply without local negotiation.
Call to action
Share this information across your organisation to all those who may be currently involved in commercial costings or contracts of Phase I, IIa or ATMP clinical trials.
Read the new templates.
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