Drug Evaluation Committee 2013-33 Concurrent positions of principal investigators, etc. in the same clinical trial and multiple medical institutions
Related classification: Principal investigators, subinvestigators, etc.
Date of first publication: November 2013
Question
We are planning to ask a physician belonging to another medical institution who comes to our hospital on a part-time basis to participate in a clinical trial to be conducted at our hospital as a subinvestigator. The sponsor has informed us that this physician is also scheduled to participate in the same clinical trial as a principal investigator at another medical institution.
This is the first time for both the sponsor and our hospital to respond in this way. Is there any problem with being both a principal investigator and a sub-investigator in the same clinical trial at different medical institutions?
Opinion of the Pharmaceutical Cooperative Association
There is no problem under GCP for a physician to serve as both a principal investigator and a subinvestigator at different medical institutions, even for the same clinical trial, as long as the physician is able to perform his/her respective duties without any problems.
Some medical institutions may have a policy that part-time physicians cannot be principal investigators or subinvestigators, so it is recommended that you check the hospital regulations beforehand.