Drug Evaluation Committee 2009-19 Scope of "Investigator-Related Committee Members" (Part 3)
Related classification: Clinical Trial Review Committee
First published: January 2010
Question
Recently, a clinical trial application was submitted to our hospital for review of a clinical trial to be conducted in two different departments (two departments, (1) and (2), respectively) under the same clinical trial protocol.
Since one of the investigational review committee members was a doctor of the department applying for (1), we thought it would not be possible to conduct a fair review and decided not to be involved in the vote on (1), but only in the review of (2).
However, we subsequently received a complaint from the sponsor that it was problematic for the same committee member to be involved in the review of (2), since the protocols were the same. The secretariat believes that our response is acceptable under GCP, but as the sponsor claims, please tell us whether we should treat such a case as one in which an impartial review cannot be conducted.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
（If the physician in the department applying for (1) is a principal investigator, subinvestigator, or collaborator of the clinical trial, he/she cannot participate in the deliberation and voting for the clinical trial, as stipulated in Article 29, Paragraph 1, Item 3 of the GCP. However, if neither of these is the case, we do not see any problem with participating in the deliberations and voting on the implementation of the clinical trial in department (1) and department (2).
(See also our opinion in 2011-13 )