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 amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
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
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The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
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First published.
Update history
2026-04-28 00:01
The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.
2026-04-16 10:37
First published.