Drug Evaluation Committee 2021-37 Review by a Clinical Trial Review Committee of the Deletion of a Clinical Research Assistant
Related classification: Clinical Trial Review Committee
Date of first publication: October 2021
Question
With regard to the deletion of a subinvestigator, the revised GCP guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3) clearly states that "In addition, the deletion of a subinvestigator that affects the system for conducting a clinical trial must be reviewed by the investigational review committee.This interpretation is the same as the 2013-13 opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ), which states, "It is recommended that the IRB does not uniformly review the deletion of investigator-in-charge, but rather determines whether or not review is necessary, taking into consideration individual circumstances. Is it correct to say that the IRB should review only when the deletion of the investigator-in-charge affects the clinical trial implementation system, and when the deletion of the investigator-in-charge does not affect the clinical trial implementation system, the IRB review is not required?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
IRB review for removal of a clinical research assistant investigator is not uniformly required, but is necessary when it affects the clinical trial implementation system. The recent revision of the GCP guidance clarifies this point.The impact on the clinical trial implementation system is likely to vary depending on the work performed by the investigator to be removed, the number of remaining investigators, and other factors. Therefore, we believe that the investigator needs to carefully examine whether or not the clinical trial can be conducted appropriately even after the removal of the investigator, and carefully determine whether or not a request for IRB review is necessary.