Drug Evaluation Committee 2008-37 Procedures for Selection of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
Date of first publication: Mar. 2009
Question
Regarding the selection of a Clinical Trial Review Committee (GCP Article 27, Paragraph 1, Operational Notification), a sponsor asked us if it would be included in the procedure manual. For example, it seems that the following text is necessary.
"The Director may request the investigation and deliberation of a requested clinical trial by selecting an appropriate Investigational Review Committee in accordance with the provisions of Article 27, Paragraph 1 of the GCP."
Is this necessary? Our hospital has traditionally reviewed all trials by its own Clinical Trial Review Committee, and we have established procedures, etc. on that basis.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 27, Paragraph 1, Guidance 2 of the GCP stipulates that "the director of the site shall establish the procedures necessary for selecting an appropriate clinical trial review committee. This is considered to be the procedure for "the head of the site shall select the appropriate investigational review committee for each clinical trial from the investigational review committees listed in (1) through (8) below, and request the committee to conduct investigation and deliberation. This is considered to be the procedure for
If a clinical trial review committee that is considered to be capable of conducting appropriate investigations and deliberations is established for all clinical trials (in the field of medicine) conducted at the relevant medical institution, and it is not expected to request an external clinical trial review committee to conduct investigations and deliberations, then it is considered that "the investigational review committee established by the head of the medical institution shall be requested to conduct the requested clinical trial. If you do not intend to request an external Clinical Trial Review Committee, there should be no problem if you clearly state in the procedure manual that "the investigations and deliberations of the requested clinical trial shall be requested to the ●●●● Clinical Trial Review Committee established by the head of the site" or if it is clear in the procedure manual to that effect. In addition, in order to appropriately investigate and deliberate clinical trials in various medical fields, it is necessary to have an appropriate composition of committee members and to be in a position to ask for the cooperation of experts in special fields other than the committee members when necessary.