The Medicines for Human Use (Clinical Trials) Regulations 2004

[F1Notification of serious breachesU.K.

29A.—(1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of—

(a)the conditions and principles of good clinical practice in connection with that trial; or

(b)the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25,

within 7 days of becoming aware of that breach.

(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree—

(a)the safety or physical or mental integrity of the subjects of the trial; or

(b)the scientific value of the trial.]

Textual Amendments