Drug Evaluation Committee 2011-58 Holding a Clinical Trial Review Committee Meeting by Videoconference
Related classification: Clinical Trial Review Committee
First published: May 2012
Question
Our hospital and the university to which we belong are in the process of relocating, and the School of Medicine and basic course departments have already moved to a new location. As a result, various meetings in the hospital have been held via videoconference since last year. Is there any problem with conducting the Clinical Trial Review Committee via videoconference as well?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 28, Paragraph 2 of the GCP includes items related to the operation of meetings as items to be included in the procedures manual of the Clinical Trial Review Committee. Therefore, if the procedure stipulates that meetings can be held via videoconference, and if the venue, videoconferencing equipment, and distribution/presentation of discussion materials are appropriately set up and operated, there should be no problem with holding a Clinical Trial Review Committee meeting via videoconference. However, it should be noted in the record of the meeting that the meeting was held via videoconference and who participated and from which location.
For your information, on February 16, 2006, the Evaluation and Management Division of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare (MHLW) issued a request for opinions and information on the "Draft Ministerial Ordinance Partially Amending the Ministerial Ordinance Concerning Standards of Implementation of Clinical Trials for Pharmaceuticals Pertaining to Clinical Trial Review Committees" and, in response to the public comments received at that time, on June 7, 2006, the MHLW issued the following response In response to the public comments received on June 7, 2006, the Evaluation and Management Division of the Pharmaceutical and Food Safety Bureau of the Ministry of Health, Labour and Welfare expressed the following views.
Comments on Public Comment
However, if it is possible to conduct deliberations by videoconference or other means that are equivalent to those conducted in a single meeting, the application of this amendment may be exempted. The proposed case is a case of IRB deliberation.
Response from the Division of Examination and Management
We believe that the case you are proposing calls into question the IRB's means of deliberation and should be determined by the individual IRB's responsibility.