Drug Evaluation Committee 2011-33 "Officers" in Clinical Trial Review Committees Established by Academic Societies
Related classification: Clinical Trial Review Committee
First published: December 2011
Question
With regard to the "officers" of the establisher of a clinical trial review committee as stipulated in Article 27, Paragraph 2 of the GCP, could you please tell us the scope of "officers" of a clinical trial review committee established by an academic society? Am I correct in understanding that only the board members of an academic society fall under the category of "officers" and that councilors are not included?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 27, Section 2, Paragraph 2 of the GCP (GCP Article 27, Section 2, Paragraph 2) also states that "officers (including persons who have authority or control equivalent to or greater than that of an officer under any name). Generally speaking, directors, auditors, accounting counselors, directors, executive officers, directors, auditors, etc. are considered to be equivalent positions.
In general, trustees are not considered to be involved in the execution of business of the association, but the duties and authority of "trustees" may vary from association to association. Therefore, we recommend that you check with the relevant academic society regarding the position of trustees.