The model agreements for use with participating NHS and HSC organisations were published on 8 April 2026 and have been updated to reflect changes to clinical trials regulations applying to clinical trials of investigational medicinal products (CTIMPs), which come into force on 28 April 2026.
Policy changes for studies which are not clinical trials of investigational medicinal products (referred to as non-CTIMPs) also take effect from 28 April 2026.
The changes to the model agreements apply to both CTIMP and non-CTIMP studies.
Updates have also been made to the model agreements for use when commercial sponsors and CROs contract with an NHS or HSC organisation to provide chief investigator services. The updates align with the amended clinical trials regulations and contain updated chief investigator fees for use in the financial year 2026-27.
The guidance documents for the commercial model clinical trial agreements (mCTAs) and the model non-commercial agreement (mNCA) give more information about the individual changes made to these agreements.
All changes have been reviewed and approved by the “Four Nations Contract Leads” group, which is responsible for managing and maintaining the model agreements published on the IRAS website.
What is required?
New studies submitted in 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. We recommend that applicants start preparing the agreements for submissions to be made from 28 April using the updated versions.
If a chief investigator is to be contracted using one of the commercial chief investigator agreements, the April 2026 version of the relevant agreement may need to be entered into before 28 April 2026. This only applies if you intend to submit the study application on IRAS on or after 28 April 2026.
You do not need to update or replace agreements for participating NHS and HSC organisations 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. You do not 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.
Make sure you are ready to use the updated agreements from 28 April 2026. Review the changes now and check that others in your organisation, such as your organisational signatories, know about the changes relevant to them, so that contracts can continue to be signed as quickly as possible.
Which agreements does this apply to?
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:
- model non-commercial agreement (mNCA)
- organisation information document for non-commercially sponsored projects
- model non-commercial hub and spoke agreement
Your feedback is important
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” group.
All contracts are reviewed every six months and updated as needed, based on feedback. Please do continue to tell us what you think.
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.