Drug Evaluation Committee 2008-28 Concurrent Appointment of Non-Expert Committee Members and Non-Hospital Committee Members (How to Write Notification of Clinical Trial Review Results)
Related classification: Clinical Trial Review Committee
Date of first publication: Mar. 2009
Question
I asked the Pharmaceutical Manufacturers Association of Japan (PMAJ), not the Japan Medical Association Clinical Trial Promotion Center, how to fill out the Uniform Form, because the content is related to GCP.
Question
In "Form 5: Notification of Results of Clinical Trial Examination", there is a note outside the column as follows. An SMO asked the Center for Promoting Clinical Trials of the Japan Medical Association if it is acceptable to write "(1) (2)" or the like in the column for committee member classification, and they replied that it is acceptable to write them together. (I have heard that this was also explained at the Clinical Evaluation Committee meeting held in February of this year.)
Note: Committee member categories should be listed by number according to the following categories.
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1.Non-expert committee member
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2.Committee members who have no vested interest in the site (excluding the committee members in 1)
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3.Members who have no vested interest in the investigational review committee (excluding member 1)
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4.Committee members other than 1 to 3
I think that it is not good to have the same person reviewing the same protocol as a non-expert in the case of a new protocol and as an external committee member in the case of a continuation protocol, even if they are reviewing different protocols.
In other words, there may be a concurrent listing of "(2)(3)", but we think that there cannot be a concurrent listing of "(1)(2)" or "(1)(3)", but what do you think?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
There is no problem under GCP in designating a certain member as a member who can serve as both a non-expert member and an external member. However, it is necessary to clarify whether the member is participating in the role of non-expert or external member in each review. That is, the same member cannot simultaneously serve as both a non-expert member and an external member in a given review meeting (GCP Article 28, Paragraph 1 Guidance 1 and Article 28, Paragraph 2 Guidance 3).
Furthermore, as long as the Clinical Trial Review Committee obtains the opinions of both non-experts and external committee members when reaching a conclusion (i.e., the requirements for the establishment of a Clinical Trial Review Committee are met), there should be no problem with the above committee members participating in the review of the same clinical trial in different roles, sometimes as a non-expert and sometimes as an external committee member. I don't think there is any problem with such members participating in the review of the same clinical trial in different roles, sometimes as non-experts and sometimes as external members.
When referring to the "role of committee members," there are two possible ways of describing the role of a committee member: (A) the range of roles that the committee member can play (clarified at the time of committee member appointment), and (B) the role of the committee member in each review (clarified before each review). However, it does not matter which method is used in the "Committee Member Classification" column of the clinical trial review report.