Drug Evaluation Committee 2018-43 Clinical Trial Review Committee Meetings in the Absence of the Chair and Vice-Chair
Related classification: Clinical Trial Review Committee
Date of first publication: January 2019
Question
In a clinical trial review committee at a medical institution, the committee is chaired by a physician affiliated with the institution and vice-chaired by a physician affiliated with an affiliated institution. In the case of physicians, there is a possibility that they may have to attend to urgent cases unexpectedly. In the past, when the chairperson was absent due to an emergency, the vice-chairperson has performed his/her duties in his/her place, although this has happened only rarely.
My question is, in the unlikely event that both the chairperson and vice chairperson are absent due to an emergency, does that mean that the Clinical Trial Review Committee meeting cannot be held? Incidentally, the SOP for the Clinical Trial Review Committee states in the clause "Establishment and Composition of the Clinical Trial Review Committee" that "If the Chair is unable to perform his/her duties for any reason, the Vice-Chair shall act on his/her behalf.
As I have not been able to derive an appropriate opinion on this matter on my own, I would appreciate your opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In a case like your question, if the requirements for holding a meeting are satisfied and a member who can act as the chairperson as stipulated in the SOP of the Investigational Review Committee attends in place of the chairperson and vice-chairperson, and if it can be judged that the Investigational Review Committee can appropriately conduct its review, it is possible to hold the meeting even if the chairperson and vice-chairperson are absent. However, if such a committee member is acting as the chairperson, the meeting may be held in his/her absence.
However, it would be necessary to record the circumstances, including prior confirmation by the chairperson, regarding such a member acting as the acting chairperson.