Drug Evaluation Committee 2012-04 Scope of "Investigator-Related Committee Members" (Part 4)
Related classification: Clinical Trial Review Committee
First published: June 2012
Question
At our hospital, all matters related to clinical trials are discussed and voted on by the in-house Clinical Trial Review Committee. In addition, for the smooth implementation of clinical trials, the Clinical Trial Management Center has been established as an organization directly under the Director, and is staffed with people who perform duties such as the Clinical Trial Secretariat, IRB Secretariat, CRC, etc. One of the IRB members is a member of the Clinical Trial Management Center, which is under the direct supervision of the Director.
One of the IRB members is the deputy director of this Clinical Trial Management Center. Is this a problem under GCP as a requirement for IRB members?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the "Deputy Director of the Clinical Trial Management Center" in question is a person who can fully deliberate on clinical trials from ethical and scientific viewpoints, as stated in Article 28, Paragraph 1, Item 1 of GCP, then he/she meets the requirements for IRB members.
On the other hand, Article 29, Paragraph 1, Item 3 of the GCP stipulates that the head of the implementing medical institution, principal investigator, etc. or collaborator cannot participate in the deliberation and voting on the clinical trial subject to review. The "Deputy Director of the Clinical Trial Management Center" is in charge of the department to which the Clinical Trial Office and CRC belong, but there is no problem with his/her participation in the deliberation and voting of the clinical trial unless he/she is a principal investigator, subinvestigator, or collaborator of the clinical trial.
Please also refer to the previous Opinion 2009-16.