Drug Evaluation Committee 2007-10 Attendance of both members is required when more than one non-expert member (Clinical Trial Review Committee) is appointed.
Related classification: Other
Date of first publication: Jan. 2008
Question
Two members are nominated as the composition of the Clinical Trial Review Committee under Article 28, Paragraph 1, Item 3 of GCP. Most of the committees nominate more than one member in order to fulfill the requirement that one member must be present at the meeting. However, how should we correct this situation if the committee thinks that at least one member must attend the meeting and the others are substitutes in case one member is unable to attend?
I believe that ongoing research and deliberation is not so much about the committee as it is about the committee members who attend. If the same committee member is absent from every committee meeting, but the requirements for a meeting are met, I wonder if this would also be pointed out in the on-site survey.... Are you aware of any such cases?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the clinical trial review board (hereinafter referred to as "IRB"), two members of GCP Article 28, Paragraph 1, Item 3 (hereinafter referred to as "non-expert members") have been nominated as background, and you say, "In order to meet the requirements for the establishment of a meeting, consideration should be given to ensure that one member can attend," but GCP Article 28, Paragraph 1, Guidance 3 says, "The composition of the committee members should be However, Article 28, Paragraph 1, Guidance 3 of the GCP stipulates that "it is necessary to maintain the composition of the committee members at an appropriate ratio. Therefore, please check whether the ratio of members of No. 3, No. 4 or No. 5 to the total number of IRB members is in accordance with the guidance.
If the ratio of professional members is significantly high, please consider changing the formation requirement to require the attendance of two non-professional members. If the ratio of non-expert committee members is judged to be appropriate, there is no problem under GCP even if only one non-expert committee member attends the meeting as it is now. You may also consider having a substitute committee member attend as much as possible to enhance his/her experience and skills.
There is no provision in GCP that the exact same committee members who were on the initial review must conduct the continuing review. Even if the members of the initial review are changed due to the election of new members, there should be no problem as long as the IRB uses the same criteria for the review.