Sunday, November 10, 2024 1:46:16 PM
https://ct.catapult.org.uk/news/regulatory-round-up-october-2024
National Health Service (NHS) England
National contract value review; advanced therapeutic medical products (ATMPs) will be incorporated
From October 2024, as part of work to accelerate commercial research setup in the UK, the National Contract Value Review (NCVR) will incorporate clinical trials of ATMPs. The NCVR is a standardised, national approach to costing for commercial contract research. To support this change, a new model clinical trial agreement for ATMPs and a new clinical research organisation (CRO) model clinical trial agreement for ATMPs are 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. With this, ATMP clinical trials now have new pre-agreed template agreements, which should be used without modification for all phases of ATMP clinical trials.
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