Reference:GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 3 (1) - (5)

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 2 — Unit 2.2.1
Scope	HM
Document part	Article 3 (1) - (5)
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Sponsor, Definition, Clinical trial

Content

Sponsor of a clinical trial 3.—(1) In these Regulations, subject to the following paragraphs, “sponsor” means, in relation to a clinical trial, the person who takes responsibility for the initiation, management and financing (or arranging the financing) of that trial.

(2) If two or more persons take responsibility for the matters specified in paragraph (1) in relation to a clinical trial, those persons may—

(a)take joint responsibility for carrying out the functions of the sponsor of that trial under these Regulations; or (b)allocate responsibility for carrying out the functions of the sponsor of that trial in accordance with paragraphs (4) to (10). (3) If two or more persons take joint responsibility in accordance with paragraph (2)(a)—

(a)any reference to the sponsor in these Regulations shall, in relation to that trial, be construed as a reference to those persons; and (b)paragraphs (4) to (10) shall not apply. (4) One of the persons referred to in paragraph (2) shall be responsible for carrying out the functions of a sponsor under Part 3 (authorisation for clinical trials and ethics committee opinion) and shall make the request for authorisation to conduct the trial in accordance with regulation 17.

(5) The request for authorisation referred to in regulation 17 shall specify—

(a)who, in accordance with paragraph (4), is responsible for carrying out the functions of the sponsor under Part 3; (b)who is to be responsible for carrying out the functions of the sponsor under Part 4 (good clinical practice and the conduct of clinical trials); and (c)who is to be responsible for carrying out the functions of the sponsor under Part 5 (pharmacovigilance).