Drug Evaluation Committee 2013-08 Scope of Non-expert Members of Clinical Trial Review Committee (Part 4)
Related classification: Clinical Trial Review Committee
First published: Jul 2013
Question
Article 28, Paragraph 1, Item 3 of the GCP states that "Among the committee members, persons other than those with expertise in medicine, dentistry, pharmacology, or other medical care or clinical trials shall be added.
We include the administrative director among the members of the committee. The current person in charge is the administrative director, who is a licensed nurse. Although she has studied the expertise, she does not use that qualification in her actual job. Should he still be considered a professional committee member? Would it be difficult to consider him as a non-professional member? I would like to confirm this, although it is natural for me to think so since I am qualified.
Opinion of the Pharmaceutical Association
A nurse falls under the category of "a person with expertise in medicine, dentistry, pharmacy, other medical care or clinical trials.
Although you are not currently engaged in nursing work, it is necessary for a person who falls under the category of "a person other than a person with expert knowledge" as defined in Article 28, Paragraph 1, Item 3 of the GCP to participate in the deliberations and voting by the Clinical Trial Review Committee, and the purpose of this is to ensure the appropriateness of the clinical trial from the perspective of a person without expert knowledge. The purpose of this provision is to request opinions on the appropriateness of the clinical trial from the viewpoint of those who do not have expert knowledge. Therefore, we do not think it is appropriate to nominate them as non-expert committee members.