Drug Evaluation Committee 2010-18 Division of Roles between Specialized Clinical Trial Review Committees and their own Institutional Review Boards (Part 1)
Related classification: Clinical Trial Review Committee
First published: August 2010
Question
As a result of a questionnaire survey of IRB members at several sites, the following comments were received regarding the review of safety information.
If only the safety information provided by the sponsor is reviewed by another review organization (IRB), such as the Central IRB, and the results are reported by the Investigator Site's IRB, then there should be no need to go to the trouble of reviewing the information. If the safety information has been properly reviewed by a specialized organization and that organization has determined that there is no problem with the continuation of the clinical trial, then there is no need to go to the trouble of having your own IRB review the information."
I think it is true that there is no problem under GCP to hear opinions from multiple IRBs, but what about the fact that there is no need for review by one's own IRB because other IRBs have determined that there is no problem? Can this be addressed in the future?
JPMA's Opinion
As stipulated in GCP Article 30, Paragraph 4, when the Investigator Site Chairperson deems it necessary to have the Investigator Site investigate and deliberate on specific specialized matters that form the premise for determining the appropriateness of conducting a clinical trial, he or she may, with the consent of the investigational review committee concerned, obtain the opinion of a clinical trial review committee other than the investigational review committee concerned (a specialized clinical trial review committee) on the said specialized matters. In such a case, the opinions of a committee other than the relevant Clinical Trial Review Committee (Specialized Clinical Trial Review Committee) may be heard. In this case, as stipulated in Paragraph 5 of the same Article, the Chairperson of the Investigator Site must report the opinions of the expert investigational review committee to the investigational review committee that heard the opinions regarding the appropriateness of conducting the clinical trial at the Investigator Site. Furthermore, the latter Investigator Site's review committee must state its opinion on the appropriateness of conducting the clinical trial based on the opinion of the expert investigator committee (Article 32, Paragraph 5 of the GCP).
The request for review by the Specialized Investigational Review Committee is based on the assumption that there are no members of the Investigational Review Committee who can provide expert opinions on the trial to be reviewed. We believe that a clinical trial review committee that has a specialized organization review the safety information in question is not fulfilling its responsibilities as a clinical trial review committee, and we recommend that the review be outsourced to an external clinical trial review committee.