Drug Evaluation Committee 2015-26 Agenda Title in the Minutes of the Clinical Trial Review Committee Meetings
Related classification: Clinical Trial Review Committee
Date of first publication: December 2015
Question
This question is about how to describe the agenda title of a deliberative clinical trial in the minutes of a Clinical Trial Review Committee.
Since GCP Article 28, Paragraph 2, Guidance 1 states that "the establisher of the clinical trial review committee shall prepare a record of the ・・・・・ meeting and a summary of the meeting," it seems to me that the agenda title in the minutes of the clinical trial review committee meeting must include all of the "sponsor name, target patients, investigational drug code and development phase" listed in the minutes for publication, which are "the summary thereof. The CRO pointed out that the agenda must include the sponsor's name, target patients, investigational drug code, and development phase, all of which are listed in the publicly available minutes. The agenda of the Clinical Trial Review Committee meeting at my site, for example, states "1) Clinical trial in the department of △△△ (clinical trial code 00000-00)".
According to the monitor, it is strange to see language in the public minutes that is not included in the original minutes. Personally, I took the summary to be a summary of the content of the minutes, but I wonder if this is also true for every word of the language. There is no agreement in GCP on how the minutes should be written, and since the investigational new drug code is listed, it can be identified and I don't think there is any problem....
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "Summary of the Record of the Meeting" of the Clinical Trial Review Committee is intended for publication to the public, and the standard method of describing the agenda is specified in GCP Article 28, Paragraph 2, Guidance 6 (2).
On the other hand, the "record of meetings" (so-called "minutes") in GCP Article 28, Paragraph 2 is an internal record of the Clinical Trial Review Committee and is not intended to be made public, and GCP does not specifically stipulate how to include agenda items in the minutes.
Therefore, as long as the agenda of a clinical trial can be identified in the minutes, it is not necessary to conform to the way the agenda is described in the "Summary of the Record of the Meeting," and it is not necessarily necessary to include the "component symbol, sponsor name, development phase, and target disease name.