Drug Evaluation Committee 2016-17 Order of Preparation of Clinical Trial Review Committee Meeting Records and Agendas for Public Release
Related classification: Clinical Trial Review Committee
Date of first publication: August 2016
Question
We have sent you an email to ask for your clarification of some points raised by the sponsor to the Investigational Review Board (IRB) that we do not understand the validity of.
Problems pointed out by the sponsor
The sponsor pointed out (1) the minutes for publication (summary of meeting minutes) and (2) the procedures for preparing the minutes (meeting transcripts). The sponsor's opinion was that (1) the minutes for public disclosure (summary of meeting minutes) should be prepared after (2) the minutes (meeting minutes) are prepared, and that if this order is not followed, the procedure should be reviewed. The IRB's position on this point is that there is no need to specify the order in which the minutes are to be prepared, since GCP does not specify the order in which the minutes are to be prepared.
The IIRB has not established a specific order for the preparation of the minutes of meetings (1) and (2), but we begin preparing the minutes of each meeting as soon as possible after the IRB meeting. The details of the IRB's minutes are as follows.
Operation of the preparation of IRB minutes
The IRB prepares (1) minutes (records of meetings) and (2) public minutes (summaries of meeting records) separately.
(1) Minutes for public access (summary of meeting record)
- Only the date, time, place, names of attending committee members, agenda, and details of deliberation results are described.
- FIX time is approximately 2 weeks after the IRB
- Prepared by IRB administrative staff and reviewed and approved by the IRB chairperson.
- The date approved by the IRB chair is the date the minutes are prepared.
(2) Minutes for public use (meeting record)
- In addition to the date, time, place, names of committee members in attendance, agenda, and results of deliberations, the minutes also include questions and answers and comments by committee members during the deliberations and vote.
- FIX time is approximately one month after the IRB is completed
- Prepared by IRB administrative staff and reviewed and approved by the IRB chairperson.
- The date approved by the IRB chair is the date the minutes are prepared.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Under GCP, there are no specific provisions regarding the order in which the minutes for public access ("summary of the record of the meeting" as referred to in Article 28.3 of GCP) and the minutes ("record of the meeting" as referred to in Article 28.2 of GCP) are prepared. Therefore, as long as each record is prepared accurately and in a timely manner, the order is not required.