Drug Evaluation Committee 2008-11 Scope of Non-expert Members of Clinical Trial Review Committees (Part 1)
Related classification: Clinical Trial Review Committee
First published: January 2009
Question
I have a question regarding the composition of non-expert members of a Clinical Trial Review Committee.
-
1.May we consider care workers and home helpers as non-professional committee members?
-
2.GCP Article 28 (Composition of Clinical Trial Review Committee, etc.), Paragraph 1, Item 3: "Of the committee members, those who do not have expertise in medicine, dentistry, pharmacy, or other medical care or clinical trials..." What does "other medical care" refer to? If you could provide us with specifics, we would appreciate it. Does welfare fall under this category?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 1, Item 3 of the GCP stipulates that "Among the committee members, persons other than those with expertise in medicine, dentistry, pharmacy, or other medical care or clinical trials shall be added," and Article 28, Paragraph 1, Guidance 1 (2) of the GCP stipulates that "At least one of the committee members shall belong to a field other than natural sciences such as medicine, dentistry, or pharmacy. at least one of the committee members must belong to a field other than natural science, such as medicine, dentistry, or pharmacy. The GCP Ministerial Ordinance and Guidance state that
These GCP Ministerial Ordinances and Guidance do not specifically define what fields or domains "other expertise in medicine or clinical trials" or "natural science" refers to. However, it is assumed that it refers to those involved in medical technology-related occupations, such as nurses, clinical technologists, dental hygienists, physical therapists, and radiology technologists, to give an example of occupations related to medical institutions.
The caregivers, home helpers, and other social workers you mention in your question are considered to be professionals in the field of nursing care rather than in the field of medical care, and thus would fall under the category of non-professionals.