PART 4 U.K.GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL TRIALS

[F1 Notification of serious breaches U.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

F1 Reg. 29A inserted (29.8.2006) by The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (S.I. 2006/1928), regs. 1(1), 16