Proposed changes to the Clinical Trial Agreement

On behalf of the UK's Four Nations Contract Leads, the Health Research Authority (HRA) is asking for your feedback on some 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 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.

Although we are only sharing the proposed draft of the model Clinical Trial Agreement (mCTA) for feedback, the changes made to the final version will be reflected across the full suite of template commercial contract model agreements as appropriate. 

The Four Nations Contacts Leads will also be updating and aligning the model non-commercial agreement (mNCA) with the updated Clinical Trial Regulations before they come into force. 

Share your feedback

The HRA is asking you to share your feedback on the proposed draft model Clinical Trial Agreement (mCTA) by Sunday 30 November 2025.

Email the team and share your feedback.

For more information, visit the HRA website.