Drug Evaluation Committee 2013-51 Vacancies of Clinical Trial Review Committee Members
Related classification: Clinical Trial Review Committee
First published: March 2014
Question
Please explain the composition of the Clinical Trial Review Committee and the need to revise the Standard Operating Procedures.
According to our hospital's Standard Operating Procedures, the hospital director appoints the head of the Pharmaceutical Department as a member of the Clinical Trial Review Committee. However, the position has become vacant due to the sudden retirement of the Director of Pharmacy. The duration of the vacancy is currently undetermined. In this case, would it be a violation of GCP to leave the position vacant without revising the Standard Operating Procedures?
Also, is there any problem with listing the position as a vacancy in the list of reviewers of the Clinical Trial Review Committee?
Opinion of the Pharmaceutical Manufacturers Association
GCP does not stipulate IRB members by position, so as long as the requirements stipulated in GCP Article 28.1 are met, individual deliberations and voting by the investigational review committee can be conducted even if the pharmacy director concerned is absent (vacancy).
On the other hand, since the protocol of the investigational study review committee stipulates the director of the pharmacy as a member of the committee, I assume that it is not possible to appoint someone other than the director of the pharmacy as a successor member of the committee. Since it is undesirable for the vacancy to continue, we recommend that you promptly appoint a successor to the Director of the Pharmacy Department or revise the procedures of the Clinical Trial Review Committee to establish a system that allows the appointment of a person other than the Director of the Pharmacy Department as a member of the committee.