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 new Chairperson has the same department, but his position is assistant to the director. In this case, would the investigator still be interpreted as a subordinate?
JPMA's Opinion
The Chairperson of the Clinical Trial Review Committee cannot participate in the deliberation and voting for the clinical trial in which he/she is involved as an investigator-in-charge. 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 "committee 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. We believe that there is no problem regarding the relationship between the Investigator Site's procedures and the Investigator Review Committee's procedures regarding the relationship between the investigator's department and the Chairperson of the Investigator Review Committee, and the hierarchical relationship between the two in terms of position.