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
Upon receiving a request from the Chairperson of the Investigator Site, the Clinical Trial Review Committee deliberates on the appropriateness of conducting the clinical trial and the appropriateness of continuing the clinical trial, and notifies the Chairperson of the Investigator Site of its opinion in writing. In general, appeals against the decision of the Investigator Site Review Committee are made through the Chairperson of the Investigator Site. The Chairperson of the Investigator Site will also notify the sponsor and investigator of the decision and the reasons for it. Therefore, it cannot be said that the head of the Investigator Site itself may not file an objection, but in principle, the person notified (sponsor or investigator) is expected to 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 Investigator Site.
- *Only for opinions on the appropriateness of continuation of a clinical trial regarding GCP Article 20, Paragraphs 2 and 3, the Investigational Review Committee, etc. may state its opinions in writing to the investigator and sponsor at the same time, in addition to the Chairperson of the Investigator Site.
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.