Drug Evaluation Committee 2010-19 Outside Committee Members - Scope of "Persons with No Conflict of Interest with the Investigator Site" (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?
JPMA's Opinion
If you are a prefectural employee who is not involved in the operation or management of the hospital, there should be no problem in becoming a member as a "person who does not have an interest in the Investigator Site (and the establisher of the committee)" under Article 28, Paragraph 1, Item 4 and Item 5 of the GCP.