Drug Evaluation Committee 2009-43 Change of Responsible Clinical Investigator (Part 5)
Related classification: Principal investigators, subinvestigators, etc.
Date of first release: Feb. 2010
Question
At an ongoing clinical trial site, the principal investigator was suddenly hospitalized.
After speaking with the hospital director, we have decided to go through the procedures to change the sub-clinical investigator to the principal investigator. Is it possible to have the doctor who is scheduled to be changed perform the duties of acting principal investigator until the change contract is signed?
I would like to leave a monitoring report stating that the decision was made after discussion with the director due to an unavoidable emergency situation. At the same time, I would like to ask the Clinical Trial Review Committee for expedited deliberation and have them formally deliberate on the matter at a later date in the regular review.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the principal investigator is not available, the clinical trial should normally be terminated. However, in the case of a sudden case like your question, from the perspective of protecting the safety and welfare of the subject during the ongoing clinical trial, we believe that it is unavoidable for the investigator to take action.
It is desirable to suspend matters that are stipulated to be conducted by the investigator in the GCP and study protocol, etc., until a new investigator is approved. For example, assignment of identification codes to new subjects, revision of the protocol, etc., addition of additional investigators and collaborators, all medical decisions related to the clinical trial, final signature on the case report form, etc. In addition, this case is not subject to "expedited review". Rather, it would be desirable to request an urgent meeting of the Clinical Trial Review Committee to discuss the matter as soon as possible.