The Health Research Authority (HRA) and devolved administrations, on behalf of the UK’s Four Nations Contract Leads, are asking for feedback on proposed changes to the model Clinical Trial Agreement (mCTA) and the related suite of commercial template agreements in the UK.
The Four Nations Contract Leads is the group responsible for the creation and maintenance of the UK's suite of template research agreements, as well as the policy and guidance around their use. The group regularly reviews feedback they have received, and they are proposing some changes based on recent suggestions
Proposed changes to the model Clinical Trial Agreement (mCTA)
Below are some of the proposed changes that we are asking for your feedback on:
- general – removal of the definition of 'Affiliate', and clauses re-drafted accordingly
- clause 4.21.9 – removal of reference to the 'MRC Principles and Guidelines for Good Research Practice', as there are other, more relevant references to the management of archiving
- clause 4.21.11b – change of e-archiving fee to £1,000 to reflect HSC/NHS costs more accurately
- clause 4.23 – updated the process for management of the addition of Other Trial Sites after contract execution
- clause 4.24 – added a new clause for use of a home health care provider
- clauses 12.6 - 12.8 – added new clauses to ensure clarity so as not to violate anti-kickback statute in the USA
- clause 14 – termination clauses revised to bring more clarity and consistency across the suite of commercial agreements
- clause 15.2 – updated to provide clarity that there should be a contract in place with Agents of the Parties on terms at least as stringent as in this contract
- appendix 4 clause 6.6 – added a new clause and table to include the details of other pass-through costs in the agreement
All of these proposed changes have been added as tracked changes to a new draft of the model Clinical Trial Agreement (mCTA).
The draft includes all of the proposed changes above, as well as some additional changes being made to align the future template with the updated Clinical Trial Regulations that come into force on 28 April 2026.
Feedback
We are asking you to share your feedback on the proposed draft model Clinical Trial Agreement (mCTA) by Sunday 30 November 2025.
All feedback should be sent to research.agreements@hra.nhs.uk
Any feedback received after this date may not be considered when developing the next version of the template agreements, but will be considered in any future versions.
Please note that this draft version cannot be used as part of any new study submission.
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