Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 11 - 12

Document information
Reference	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
Validity area	GBR
Scope(s)	HM
Document name	The Medicines for Human Use (Clinical Trials) Regulations 2004
Version / Revision	01-May-2004
Status	Current
Document type	Legal act
Language(s)	EN
Description	The Medicines for Human Use (Clinical Trials) Regulations 2004
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 1 — Unit 1.5.4
Scope	HM
Document part	Article 11 - 12
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Clinical trial, Ethics committee, Amendment, Regulatory submission
Comment	Authorisation and ethics opinion requirements for clinical trials

Content

PART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE OPINION Interpretation of Part 3 11. In this Part—

“amendment to the clinical trial authorisation” means an amendment to— (a)the terms of the request for authorisation to conduct that trial or the application for an ethics committee opinion in relation to that trial, (b)the protocol for that trial, or (c)the other particulars or documents accompanying that request for authorisation or application for ethics committee approval; “substantial amendment to the clinical trial authorisation” means an amendment to the clinical trial authorisation which is likely to affect to a significant degree— (a)the safety or physical or mental integrity of the subjects of the trial, (b)the scientific value of the trial, (c)the conduct or management of the trial, or (d)the quality or safety of any investigational medicinal product used in the trial; “valid application” means an application for an ethics committee opinion which complies with the provisions of regulation 14; and“valid request for authorisation” means a request to the licensing authority for authorisation to conduct a clinical trial which complies with the provisions of regulation 17, and “valid amended request” shall be construed accordingly. Requirement for authorisation and ethics committee opinion

12.—(1) No person shall—

(a)start a clinical trial or cause a clinical trial to be started; or (b)conduct a clinical trial, unless the conditions specified in paragraph (3) are satisfied.

(2) No person shall—

(a)recruit an individual to be a subject in a trial; (b)issue an advertisement for the purpose of recruiting individuals to be subjects in a trial, unless the condition specified in paragraph (3)(a) has been satisfied.

(3) The conditions referred to in paragraphs (1) and (2) are—

(a)an ethics committee or an appeal panel appointed under Schedule 4 has given a favourable opinion in relation to the clinical trial; and (b)the clinical trial has been authorised by the licensing authority. (4) For the purposes of these Regulations, a clinical trial has been authorised by the licensing authority if—

(a)in the case of a trial to which regulation 18 relates— (i)the trial is to be treated as authorised by virtue of regulation 18, or (ii)the authority has accepted the request for authorisation in accordance with the procedure specified in Schedule 5; or (b)in the case of a clinical trial to which regulation 19 or 20 applies— (i)the authority has given a notice of authorisation in accordance with those regulations, or (ii)the authority has accepted the request for authorisation in accordance with the procedure specified in Schedule 5.