Drug Evaluation Committee 2008-18 Attendance of Investigators at Clinical Trial Review Committee Meetings
Related classification: Clinical Trial Review Committee
First published: January 2009
Question
GCP Article 29, Paragraph 1, Operational Notification 6 states, "The investigator ... (omitted) ... shall not participate in the deliberation and voting on the clinical trial. Is it possible to observe? Is it possible to observe or must I leave the room? Can I observe or do I have to leave the room?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The guidance does not specify whether the investigator must leave the room for deliberation and voting by the Investigational Review Committee after the investigator has explained the content of the trial.
Although it may depend on the method of deliberation and voting at the committee meeting (a show of hands, a write-in vote, etc.), some committee members may find it difficult to vote (express their intention) if the investigator is present at the voting session. It is desirable for the clinical trial review committee members to be able to express sufficient opinions from a supervisory standpoint regarding the eligibility of the investigator and staff, as well as the facilities and support system, etc. Therefore, the clinical trial review committee needs to make a decision after considering whether this is possible even if the investigator is present. We will need to make a decision based on whether or not this is possible even if the investigator is present.