Drug Evaluation Committee 2004-08 Composition of the Clinical Trial Review Committee - Number of External Members
Related classification: Clinical Trial Review Committee
First published: December 2004
Revised publication date: March 2012
Question
Our Clinical Trial Review Committee consists of nine members, one of whom is an external member.
Due to the increase in the number of clinical trials, we are planning to increase the number of review committee members by one.
If the number of committee members increases to 10, is it acceptable to leave the number of external committee members at 1?
I thought there was a statement that one external committee member should be added to every five members, so I inquired.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 1, Guidance 3 of the GCP stipulates that "The number of committee members shall be at least five, but if the number of committee members is larger than this, the number of committee members shall be increased by increasing the number of item 3 (non-specialists), item 4 (external members who have no interest in the site) or item 5 (external members who have no interest in the establisher of the clinical trial review committee) of the same paragraph, or by other means. The number of committee members should be kept at an appropriate ratio by increasing the number of the following items. This means that the appropriate ratio of committee members must be maintained. This is because the purpose of maintaining an appropriate ratio of committee members is to ensure that the opinions of committee members in their respective positions are appropriately reflected in deliberations, and therefore, as you suggest, it would be appropriate to increase the number of external committee members. In addition, when holding a Clinical Trial Review Committee meeting, the attendance of non-expert and external committee members is essential for the meeting to be successful, so it is necessary for the committee to have multiple non-expert and external committee members appointed respectively. (We believe that attendance of at least one member each is sufficient for deliberation and voting requirements in the procedure manual.) Please confirm that the requirements for the composition of the committee members and the requirements for the establishment of a meeting are stated in the procedure manual of the clinical trial review committee.
Reason for revision of opinion
The explanation regarding the composition of the Clinical Trial Review Committee has been changed in accordance with the revision (October 24, 2011) of the "Implementation of Standards for Conducting Clinical Trials on Drugs.