Drug Evaluation Committee 2021-26 Eligibility of Clinical Trial Review Committee Members (Part 3)
Related classification: Clinical Trial Review Committee
First published: Aug. 2021
Question
Article 29 of the GCP stipulates that the head of the medical institution, investigators, or collaborators may not participate in the deliberations and voting on a clinical trial that is subject to review. Please let us know your view on the relationship between the investigator or collaborator and the clinical trial review committee members. For example, can a member of a clinical trial review committee who has been listed in the delegation log of the relevant clinical trial or other clinical trials for the relevant investigational product in the past participate in the deliberations and voting of the relevant clinical trial even when he/she is not listed in the delegation log?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In principle, no. Those who are listed in the delegation log of a clinical trial may not participate in the deliberation and voting of the clinical trial as a member of the investigational review committee (see 2017-11 ). Therefore, at the time of deliberation and voting, the involvement in the clinical trial under consideration will be judged according to whether or not the person is listed in the delegation log.
Therefore, even if the investigator is listed in the delegation log of another clinical trial for the investigational drug in question or has been listed in the delegation log of a clinical trial in question in the past, if the investigator is not involved in the clinical trial in question at the time of deliberation and voting, there is no problem with participating in the deliberation and voting of the clinical trial in question as a member of the Clinical Trial Review Committee. See also 2018-49.