Drug Evaluation Committee 2010-26 Necessity of (Clinical Trial Review Committee) Review of Investigators' Curriculum Vitae in English
Related classification: Clinical Trial Review Committee
First published: October 2010
Question
When a foreign company was contracted to sponsor a clinical trial, we were asked to submit both Japanese and English versions of the investigator's curriculum vitae. Is it necessary to review the English version of the CV at the initial Clinical Trial Review Committee meeting?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 32, Paragraph 1/Section 2, Guidance 5 of the GCP stipulates that "The Investigational Review Committee shall consider whether the investigator is qualified to conduct the clinical trial by reviewing the investigator's most recent curriculum vitae and other documents. The Guidance states that "the investigator review committee shall consider whether the principal investigator is qualified to conduct the clinical trial. In some cases, such as the case in question, the sponsor may require an English version of the CV for some reason (e.g., the sponsor's overseas headquarters confirms the investigator's eligibility, or the CV is used as an attachment to an English summary report). On the other hand, the investigator's eligibility can be reviewed by the Clinical Trial Review Committee using a Japanese CV, etc., so there is no need for the English version of the CV to be reviewed.