Drug Evaluation Committee 2009-51 Appeal to Clinical Trial Review Committee
Related classification: Clinical Trial Review Committee
First published: Mar. 2010
Revised publication date: Apr. 2013
Question
Regarding GCP Article 28, Paragraph 2, "3) Matters related to the operation of the meeting," the notice of operation includes a section titled "Procedures for Appeal against the Decision of the Committee. When I look at the hospital's procedure manual for this objection procedure, I find that in some hospitals, the person who makes the objection is the investigator or sponsor, while in other hospitals it is the hospital director. Which is correct?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The investigational review committee deliberates on the appropriateness of conducting a clinical trial and the appropriateness of continuing the clinical trial upon request from the head of the implementing medical institution, and notifies the head of the implementing medical institution of its opinion in writing. In general, appeals against the decision of the TRC are made through the head of the site. In addition, the details of and reasons for the decision of the investigational review committee will be notified to the sponsor and investigator through the head of the site*. Therefore, it cannot be said that the head of the site itself may not file an objection, but in principle, the person notified (sponsor or investigator) will file an objection.
It is desirable that the procedure for appealing the decision of the investigational review committee be stipulated in the procedure manual of the investigational review committee or the site.
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As of December 2023The Clinical Trial Review Committee, etc. may state its opinion in writing to the investigator and sponsor at the same time, in addition to the head of the investigational institution, only with regard to its opinion on the appropriateness of continuation of a clinical trial in accordance with Article 20, Paragraphs 2 and 3 of the GCP.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (December 28, 2012, Pharmaceutical Affairs Ministry, Food and Drug Administration, No. 1228-7), a note has been added regarding the notification route for the content of the decision of the clinical trial review committee.