Drug Evaluation Committee 2009-49 Temporary Substitution of a Member of a Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Mar. 2010
Revised publication date: Apr. 2013
Question
When we obtained a copy of the Investigational Review Results Report from the site, we found that one IRB member (expert/internal) had been changed. In the remarks column, it says that Mr. B will attend this meeting as a substitute IRB member since the original IRB member (Mr. A) will be away for several months for training. Please let me know your opinion.
Mr. A has not participated in the deliberations and voting because he is a cooperator in the clinical trial, but Mr. B has participated in the deliberations and voting this time.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Members of a clinical trial review committee must be appointed on an individual basis based on the knowledge and experience of the person who is to be a member of the committee. In addition, GCP does not indicate the operation of substitute committee members. Therefore, if Committee Member A is unable to attend the review meeting and the role of Committee Member A is expected to be filled by Committee Member B, then Committee Member B should be nominated as a regular committee member, not as a "substitute.
Reason for revision of opinion
We have reviewed the opinion to more clearly indicate that the method of "acting" as a committee member is not acceptable.