Drug Evaluation Committee 2012-35 Scope of Non-Expert Members of Clinical Trial Review Committees (Part 3)
Related classification: Clinical Trial Review Committee
Date of first publication: December 2012
Question
I have a question regarding the distinction between professional and non-expert members of a clinical trial review committee. Would a clinical psychologist be classified as either a professional member or a non-expert member?
GCP Article 28, Paragraph 1, Item 3 states 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 GCP Article 28, Paragraph 1, Guidance 1 states that "2) At least one of the committee members shall belong to a field other than natural science such as medicine, dentistry, or pharmacy. (2) At least one member of the committee must belong to a field other than natural science, such as medicine, dentistry, or pharmacy. The guidance states that
Some clinical psychologists are from the medical field, but some are from the humanities, such as psychology. Is it possible to consider a clinical psychologist from the humanities as a non-expert committee member who belongs to a field other than the natural sciences?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
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.
Clinical psychologists are licensed to work in a wide range of fields, including justice, education, medical care, and nursing care, after taking examinations in mental illness, clinical psychology, general psychology, psychological assessment, statistics, psychotherapy and techniques, case studies, and law. Therefore, we believe that it is appropriate to determine whether or not it is appropriate to appoint a clinical psychologist as a non-expert committee member based on the education and experience the clinical psychologist has received and the nature of his/her current work. In general, we believe that it is acceptable to nominate a clinical psychologist who has studied at an educational institution in the field of education and humanities and is engaged as a clinical psychologist in the fields of justice and education as a non-expert committee member. On the other hand, a clinical psychologist working in the medical field is part of a medical team or team medicine, so we think it is appropriate to nominate him or her as an expert member.