Drug Evaluation Committee 2010-19 External Committee Member - Scope of "Persons with No Conflict of Interest with the Performing Medical Institution" (Part 5)
Related classification: Clinical Trial Review Committee
First published: August 2010
Question
A city hospital that we support is planning to change the external committee member of the IRB established within the hospital, and an employee of the prefecture to which the city belongs is scheduled to be the next external committee member. Is this person acceptable as an external committee member?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If he/she is an employee of the prefecture who is not involved in the operation or management of the hospital, there should be no problem for him/her to be a member as "a person who does not have an interest in the site (and the establisher of the investigational review committee)" under Article 28, Paragraph 1, Item 4 and Item 5 of the GCP.