Control of Clinical Trials Act, 1987

Amendment of permission to undertake clinical trial.

5.—(1) Where, in relation to a subsisting permission granted by the Minister under section 4 (whether or not previously amended by virtue of this section), it is proposed to do, or refrain from doing, any act in relation to the proposed clinical trial or the clinical trial (as the case may be) otherwise than in accordance with the permission, then the person who applied for the permission shall make an application to the Minister for an amendment thereof and the Minister shall, after consultation with the National Drugs Advisory Board and not later than 6 weeks after the application for the amendment was so made, either agree or not agree to the amendment of the permission.

(2) Where under subsection (1) the Minister agrees to an amendment, it shall not be acted upon—

(a) in the case of a proposed clinical trial, until the ethics committee for the proposed trial has given its approval to the proposed trial (as so amended) in accordance with section 8 (2),

(b) in the case of a clinical trial which has been approved by the ethics committee—

(i) until the committee has given its approval to the amendment, and

(ii) in respect of each person to whom one or more substances or preparations are to be administered, until the person who has given or gives his consent in accordance with section 9 has been made aware of such matters (if any) as the committee considers he should be made aware of having regard to the amendment.