Drug Evaluation Committee 2018-42 Issuer of a Letter of Notification of Clinical Trial Review Results in the Absence of the Chairperson
Related classification: Clinical Trial Review Committee
Date of first publication: January 2019
Question
At a clinical trial review committee, the chairperson will be absent from the review meeting. The SOP states that when the chairperson is absent, a substitute committee member is to be appointed. The review meeting itself was held without any problems, but I am having a problem with the description in the Notification of Clinical Trial Review Results form.
The chairman's name is written at the upper right corner of the form, but even if he/she is absent, is it correct to leave the chairman as the issuer of the notification form? I have considered the following suggestion, but I am having trouble with it.
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It shall be issued in the name of a substitute committee member appointed by the chairperson.
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The chairperson will issue it on the date after the review meeting, assuming that the chairperson confirms the contents at a later date.
In GCP, it is not "the chairperson" but "the clinical trial review committee reviews and expresses its opinion in writing".
The column for "Issuer" on the Notification of Clinical Trial Review Results is "Chairperson," but some clinical trial review committees are issued by a vice-chairperson appointed by the chairperson. I think the thinking is that since the chairperson is absent on the day of the meeting, the committee cannot make a decision on approval, but there is also the thinking that if the review is being conducted properly, the chairperson can issue the notification even if he or she is not present at the review meeting.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 32, Paragraph 1 of the GCP, when the head of the investigational institution asks for an opinion on the appropriateness of conducting a clinical trial, the investigational review committee must conduct a review and state its opinion in writing. However, it does not specify who (role) of the investigational review committee should issue the document.
In addition, the "New Uniform Form for Requesting a Clinical Trial "* states that the document (Notification of Results of Clinical Trial Review) shall be issued in the name of the chairperson, but it does not state how to handle cases such as the one you are asking about.
In such cases, either method (1) or (2) in your question may be used. However, it is recommended that the person to issue the Notification of Clinical Trial Review Results in such a case be stipulated in advance in the procedures of the Clinical Trial Review Committee.
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As of December 2023July 10, 2008 Medical Affairs Bureau, Ministry of Health, Labour and Welfare, Medical Affairs Bureau, Director of Research and Development Promotion Division, No. 0710 No. 4 / Pharmaceuticals and Medical Devices Evaluation and Management Division, Pharmaceuticals and Life Sanitation Bureau, Ministry of Health, Labour and Welfare, Director of Pharmaceuticals Evaluation and Management Division, No. 0710 No. 2 / Medical Devices Evaluation and Management Division, Pharmaceuticals and Life Sanitation Bureau, Notification.