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?
JPMA's Opinion
The Clinical Trial Review Committee deliberates on the appropriateness of conducting a clinical trial and the appropriateness of continuing the clinical trial upon request from the Chairperson of the implementing medical institution, and notifies the Chairperson of the implementing medical institution of its opinion in writing. In general, appeals against the decision of the investigational review committee are made through the Chairperson of the site. In addition, the Chairperson of the site will notify the sponsor and investigator of the decision and the reasons for it. 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.
- *The Clinical Trial Review Committee can give its opinion in writing to the investigator and sponsor as well as the Chairperson of the investigational institution regarding the appropriateness of continuation of the clinical trial in accordance with Article 20, Paragraphs 2 and 3 of the GCP.
Reason for revision
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.