Guidance
Clinical Trials Regulations enforcement provisions
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
Documents
Details
The guidance document explains that under the amended Clinical Trials Regulations, the provisions against which an infringement notice or an offence can be raised have been expanded, primarily to reflect changes in legislation as a result of this amendment. The amendment to the Regulations also brings the ability to issue infringement notices against the same provisions which, if contravened, constitute an offence to facilitate a proportionate and pragmatic approach.
Updates to this page
Published 12 January 2026