Drug Evaluation Committee 2009-16 Scope of "Investigator-Related Members" (Part 2)
Related classification: Clinical Trial Review Committee
First published: Jul. 2009
Question
The chairperson of the Clinical Trial Review Committee will be changed. The investigator in charge of the clinical trial currently underway is the new chairperson. Therefore, I removed him from the investigator-in-charge. Is it possible to avoid "GCP Article 29, Paragraph 1, Item 1" by doing so?
The investigator is the head of the department concerned, but the position of the new committee chair is assistant to the director, although the department is the same as the investigator's. In this case, the investigator is the same as the new committee chair. In this case, would the investigator still be interpreted as a subordinate?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The chairperson of the investigational review committee cannot participate in the deliberation and voting of a clinical trial in which he or she is involved as a subinvestigator. Therefore, he/she cannot participate in the deliberations for the deletion of the investigator's role as a subinvestigator, but there is no problem with the subsequent deliberations for the said clinical trial.
The term "members related to the investigator" as stipulated in Article 29, Paragraph 1, Guidance 1 of the GCP is understood to mean the investigator, subinvestigator, and collaborator. There should be no problem regarding the relationship between the department to which the investigator belongs and the hierarchical relationship between the chairperson of the investigational review committee and the investigator in terms of position, unless otherwise stipulated in the procedures of the medical institution or the investigational review committee.