Regulation 29 Conduct of trial in accordance with clinical trial authorisation etc.

United Kingdom

Subject to regulation 30, no person shall conduct a clinical trial otherwise than in accordance with—

(a)

the protocol relating to that trial, as may be F1modified from time to time in accordance with F2regulations 20 to 22C;

(b)

the terms of—

(i)

the request for authorisation to conduct that trial,

(ii)

the application for an ethics committee opinion in relation to that trial, and

(iii)

any particulars or documents, other than the protocol, accompanying that request or that application,

as may be F3modified from time to time in accordance with F4regulations 20 to 22C; and

(c)

any conditions imposed F5... under F6regulation 18(3), 18B(3), 22A(4), 22C(3) or Schedule 5.

Annotations

F1: Word in reg. 29(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(a)
F2: Words in reg. 29(a) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(b)
F3: Word in reg. 29(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(a)
F4: Words in reg. 29(b) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(2)(b)
F5: Words in reg. 29(c) omitted (28.4.2026) by virtue of The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(3)(a)
F6: Words in reg. 29(c) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 18(3)(b)