Drug Evaluation Committee 2010-44 Division of Roles between Specialized Clinical Trial Review Committees and their own Institutional Review Boards (Part 2)
Related classification: Clinical Trial Review Committee
Date of first publication: February 2011
Question
Is it possible to separate the roles of the home site IRB and the central IRB by function? For example, the home IRB could deliberate on safety information, and the central IRB could deliberate on other matters, and the home IRB could deliberate on whether the clinical trial should be continued or not.
We are considering establishing a joint clinical trial implementation system at multiple medical institutions, and since it would be a heavy burden for the central IRB to deliberate all the contents at the central IRB, we are thinking that the IRB at each medical institution should deliberate on safety information, and the central IRB should deliberate on the other contents. We are considering this matter. Is there any problem with this from a GCP standpoint?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The Clinical Trial Review Committee examines the appropriateness of conducting the relevant clinical trial based on the investigational new drug summary, protocol, etc. (GCP Article 32, Paragraph 1). The committee must also review the appropriateness of continuing the clinical trial based on safety information reported by the sponsor during the trial (GCP Article 20, Paragraphs 2 and 3, and Article 32, Paragraph 3). In such review, the head of the site is obliged to select an investigational review committee that is capable of conducting consistent investigations and deliberations from the start to the end of the clinical trial, and to request the committee to conduct investigations and deliberations (GCP Article 27, Paragraph 1, Guidance 2).
Therefore, it is not appropriate to separate the review of "appropriateness of conducting the relevant clinical trial" and "appropriateness of continuation of the relevant clinical trial" from the review of "appropriateness of conducting the relevant clinical trial" in terms of consistency of review.