Regulation 3 Sponsor of a clinical trial

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.

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

If two or more persons take joint responsibility in accordance with paragraph (2)(a)—

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 F1request for approval to conduct the trial in accordance with F2regulation 16.

The F3request for approval referred to in F4regulation 16 shall specify—

After the clinical trial has been F5approved in accordance with regulation 18 F6or 18A, a different person may be specified as responsible for carrying out the functions of the sponsor under Part 3, 4 or 5 by making a F7modification of an important detail as defined in Part 3 to the terms of a clinical trial F8approval in accordance with F9regulation 22.

Where a person is responsible for carrying out the functions of the sponsor under Part 3 by virtue of paragraph (5), or is specified in accordance with paragraph (6) as responsible for those functions, any reference to the sponsor in—

shall, in relation to the trial, be construed as a reference to that person.

Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 4, any reference to the sponsor in—

shall, in relation to the trial, be construed as a reference to that person.

Where a person is specified in accordance with paragraph (5) or (6) as responsible for carrying out the functions of the sponsor under Part 5, any reference to the sponsor in that Part shall, in relation to the trial, be construed as a reference to that person.

Any reference to the sponsor in—

shall, in relation to the trial, include a reference to a person specified in accordance with paragraph (5) or (6).

A person who is a sponsor of a clinical trial in accordance with this regulation must—

A person who is a sponsor of a clinical trial in accordance with this regulation may delegate any or all of his functions under these Regulations to any person but any such arrangement shall not affect the responsibility of the sponsor.

The licensing authority must publish a list of countries where a sponsor of a clinical trial, or their legal representative, may be established for the purpose of paragraph (11).

In order to determine whether a country should be included in the list referred to in paragraph (11A), the licensing authority may, in particular, take into account—

The licensing authority must—