Control of Clinical Trials Act, 1987

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Application to undertake clinical trial.

3.—(1) A person who proposes to arrange for the conducting of a clinical trial shall apply to the Minister for permission to make such arrangements before the trial is undertaken and every application for such permission shall be accompanied by—

(a) the name, address and description of the applicant,

(b) sufficient information to enable a scientific evaluation to be made of the proposed clinical trial and of the substance or preparation which it is proposed to administer in the course of that trial,

(c) the identity (which includes the qualifications of each member) of the ethics committee,

(d) the name, address and qualifications of each person who would conduct the clinical trial,

(e) the criteria to be used for the recruitment and the selection of participants,

(f) details of any proposed inducements or rewards, whether monetary or otherwise, to be made for becoming or being a participant,

(g) such further information, evidence, documents, samples and other materials as may be necessary to indicate the nature of the trial, and

(h) the appropriate fee (if any) specified by the Minister by virtue of section 16 .

(2) Where an application has been made in accordance with subsection (1) the Minister may, at any time before he makes a decision for the purpose of section 4 and whether or not he has approved of the proposed ethics committee, request such further information, evidence, documents, samples and other materials as may in his opinion assist him in making such a decision.

(3) An application under this section may be made at any time after the passing of this Act, but any application made before the day appointed by the Minister under section 19 (2) shall, for the purpose of subsection (1), be treated as if it had been made on that day.

(4) In this section “arrange for the conducting of a clinical trial” does not include any measures taken for the purpose of an application under this section.