Drug Evaluation Committee 2023-63 Scope of Non-expert Members of Clinical Trial Review Committees (Part 6)
Related classification: Clinical Trial Review Committee
Date of first publication: July 2024
Question
Regarding the IRB established in the hospital, please allow me to confirm the eligibility of IRB members for future changes of IRB members.
Is a licensed medical information manager (clerical staff) working at the facility appropriate (no problem) as a non-expert member of the hospital IRB?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The Japan Hospital Association describes a "medical information manager" as a professional who collects and manages information related to human health (health), focusing on various medical information of patients at medical institutions, based on the International Statistical Classification of Medical Information, etc., extracts, processes, and analyzes the database, and provides information suitable for various needs. The term "health professional" is used in this report.
In addition, considering the fact that to become a medical information manager, one needs to take courses such as Introduction to Medicine, Clinical Medicine, and Clinical Medicine to qualify for the certification examination, a person with "expert knowledge in medicine, dentistry, pharmacy, other medical care or clinical trials," as stipulated in Article 28, Paragraph 1, Item 3 of the GCP, must be qualified. Therefore, it is considered that a medical information manager falls under the category of "a person with expertise in medicine, dentistry, pharmacy, or other medical care or clinical trials". Therefore, it is not appropriate for a medical information manager to be a non-expert member of a clinical trial review committee.