Drug Evaluation Committee 2008-35 Curriculum Vitae of Physicians Responsible for Clinical Trials (Part 2)
Related classification: Principal investigators, subinvestigators, etc.
Initial release date: Mar. 2009
Revised publication date: December 2021
Question
According to the GCP Operational Notification dated October 1, 2008, the curriculum vitae of investigators is not necessarily required as a review document for the Clinical Trial Review Committee.
Under ICH-GCP, the curriculum vitae of a clinical investigator is one of the Essential Documents (8.2.10). Is the absence of a curriculum vitae for the investigator a problem in terms of commonality between the Japanese GCP and the ICH-GCP?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The GCP amendment dated February 29, 2008 and the GCP operation notice amendment dated October 1, 2008 were enacted and enforced in consideration of consistency with ICH-GCP.
Although the ICH-GCP text does not specify that the investigational review committee and the sponsor must obtain the curriculum vitae of the investigator, as you asked, the ICH-GCP Essential Documents states that the sponsor must obtain the curriculum vitae of the investigator. On the other hand, the ICH-GCP Essential Documents do not clearly state this.
On the other hand, in the Administrative Communication "Documents and Records Related to Clinical Trials," which corresponds to the ICH-GCP Essential Documents, it is stated that "documents such as curriculum vitae of investigators and a list of names of subinvestigators" are documents that the sponsor should obtain, and "curriculum vitae of subinvestigators upon request" is stipulated as a document that is required. Therefore, it is possible to obtain such documents when deemed necessary, so there should be no problem.
Reason for revision of opinion
The opinion text has been partially changed in accordance with the issuance of "Regarding Documents and Records Pertaining to Clinical Trials (August 31, 2020, Ministry of Health, Labor and Welfare, Pharmaceuticals and Life Sanitation Bureau, Drug Evaluation and Control Division, Office Communication)".