Drug Evaluation Committee 2014-34 Clinical Trial Review Committee when One Clinical Trial is Conducted at Multiple Medical Institutions
Related classification: Clinical Trial Review Committee
Date of first publication: December 2014
Question
I have a question related to 2004-14 (Points to keep in mind when conducting a single clinical trial at multiple medical institutions).
The hospital A and clinic B are operated under the same management style and share the same electronic medical record, and use the same standard equipment for testing at each facility. I have a question regarding the clinical trial review committee.
We would like to have a review committee for each of Hospital A and Clinic B. Can't we have the same members on the review committee for Hospital A and Clinic B? If not, to what extent are the same members allowed? There is a way to ask Hospital A's Clinical Trial Review Committee to be outsourced from Clinic B, but it seems that both institutions are supposed to hold their own Clinical Trial Review Committee. Also, is it not a bad idea to have the same members for the composition of the Clinical Trial Office at both institutions?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The form, composition and operation of the IRB are stipulated in Articles 27 through 29 of the GCP, and as long as the review is conducted in accordance with these provisions, there should be no problem. Therefore, as long as the above regulations are followed, there is no problem even if the members and secretariat members of the IRBs of Hospital A and Clinic B are the same. However, if each IRB conducts the review, the workload for the review and various procedures related to the request for a clinical trial will be required at each IRB, and the burden on the secretariat and the sponsor will double. We hope you will consider establishing a joint IRB or outsourcing the review to one of the two IRBs.