Drug Evaluation Committee 2008-21 Scope of "Investigator-Related Committee Members" (Part 1)
Related classification: Clinical Trial Review Committee
First published: January 2009
Question
Background
- The committee consists of 7 members, 3 experts, 2 external members, and 2 non-experts.
- The director is the principal investigator and there are no subinvestigators.
- One of the expert committee members sees the Director once a month in his place, but does not handle clinical trials. The sponsor has inquired about the participation of this committee member in the deliberation and voting of the IRB, claiming that the IRB cannot be established due to a violation of GCP Article 29, Paragraph 1, Operational Notice 1, which states that "Members who are related to the investigator shall not participate in the deliberation and voting of matters concerning the relevant clinical trial at the Clinical Trial Review Committee. The sponsor inquired about the IRB.
Question 1
Does the fact that a member substitutes for the investigator once a month constitute a member who has a relationship with the investigator?
Question 2
Even if a member cannot participate in the deliberation and voting, I believe that a clinical trial review committee can still be formed, but would the participation of such a member cause the committee to fail?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding your question 1
The committee members who may not participate in the deliberation and voting on a clinical trial subject to review are those stipulated in Article 29, Paragraph 1, Items 1 through 3 of the GCP. In addition, the Guidance does not indicate whether or not the case in question falls under the category of "investigator-related" committee members. As a general rule, given that you are not in charge of the clinical trial, there should be no problem if you are only acting as a surrogate. However, whether the committee member is actually "related to the investigator" or not would need to be determined on an individual basis based on more detailed background information.
Regarding your question 2
If a committee member who cannot participate in the deliberation as stipulated in Article 29 of the GCP participates in the deliberation and vote, the result of the deliberation of the clinical trial will be deemed to be unsuccessful (in other words, if he/she does not participate in the deliberation and vote, the result will be deemed to be successful). It is considered necessary to reconsider or reconfirm the results of deliberation at an urgent or next meeting of the Clinical Trial Review Committee.