The new clinical trials regulations will update some of the terminology in the current legislation.

This will include introducing new terms and updating the definitions for some existing terminology. This guidance provides information on the changes to the terminology set out in the legislation.

From 28 April 2026, our existing guidance, processes, systems and model agreements will be updated to make sure that the terminology we use matches the updated terminology in the legislation where appropriate.

Back to guidance on changes to the clinical trials regulations