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