Updated model agreements for use with participating NHS and health and social care (HSC) organisations should be used from today (28 April 2026).
The agreements have been updated to reflect changes to clinical trials regulations, which apply to clinical trials of investigational medicinal products (CTIMPs) and come into force today.
Policy changes for studies which are not clinical trials of investigational medicinal products (referred to as non-CTIMPs) also take effect from today.
On Wednesday 8 April we issued a HRA Now bulletin explaining what commercial and non-commercial sponsors, contract research organisations (CROs), NHS and HSC organisations, chief investigators employed by NHS or HSC organisations, and applicants need to be aware of.
Which agreements have been updated?
The following commercial agreements (and their associated guidance) have been published for use from 28 April 2026:
- model clinical trial agreements (mCTAs) – including the CRO-mCTA, the advanced therapy mCTA (ATMP-mCTA) and CRO-ATMP-mCTA, and the primary care mCTAs (bi-partite and tri-partite PC-mCTAs)
- model commercial chief investigator agreements (mCCIA) – including the CRO-mCCIA
- model clinical investigation agreements (mCIAs) – including the CRO-mCIA
- model non-interventional study agreements (mNISAs) – including the CRO-mNISA
- model commercial hub and spoke agreement
The following non-commercial agreements (and their associated guidance) have been published for use from 28 April 2026:
What do I need to do?
New studies submitted in the Integrated Research Application System (IRAS) on or after 28 April 2026 must use the April 2026 versions of the model agreements. Previous versions will not be accepted from this date.
Agreements for participating NHS and HSC organisations do not need to be updated or replaced where a contract is already in place. However, any new contracts with participating NHS and HSC organisations entered into on or after 28 April 2026 must use the April 2026 version of the relevant agreement.
There is no need to submit a modification to use an updated agreement as long as the agreement is used unaltered with only the yellow highlights completed, deleted or retained as appropriate.
How can I give feedback?
We welcome feedback on all of our model agreements. The Four Nations Contracting Leads group reviews feedback every 6 months and decides if any further changes need to be made to the contracts.
Please email your feedback to research.agreements@hra.nhs.uk.