Guidance
Clinical trials for medicines: roles and responsibilities
Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.
Documents
Details
The following guidance accompanies the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. These amendments come into force on 28 April 2026 and any reference to “the amended Clinical Trials Regulations” in this guidance should be construed as referring to the amended version.
Part 2 of Schedule 1 to the amended Clinical Trials Regulations requires that the investigator and sponsor have regard to all relevant guidance with respect to commencing and conducting a clinical trial.
Updates to this page
Published 16 April 2026