Regulation 29A Notification of serious breachesF1

(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 F2modified from time to time in accordance with F3regulations 20 to 22C,

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 F4participants of the trial; or

(b)

the scientific value of the trial.

Annotations

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
F2: Word in reg. 29A(1)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(2)(a)
F3: Words in reg. 29A(1)(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(2)(b)
F4: Word in reg. 29A(2)(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 19(3)