Drug Evaluation Committee 2010-27 Change of investigators (Part 6)
Related classification: Principal investigators, subinvestigators, etc.
First published: October 2010
Revised publication date: March 2021
Question
The investigator at one of the sites died suddenly (completely unforeseeable). The investigator's care for the subjects had been completed (final visit and submission of all CRFs after SDV), and the investigator was to submit the study completion report in a few months. The investigator's change is a matter for deliberation.
Since the change of investigator was a matter to be discussed, the IRB was prepared to hold an emergency IRB meeting. However, the sponsor requested that the IRB deliberate after the selection and agreement of the investigator and the submission of the notification of change in the clinical trial plan, as Form 10 "Application for Change in Clinical Trial" would be submitted to the head of the implementing medical institution. If we do this, the next IRB meeting will not be in time, and as a result, we will have to wait two months for the IRB to deliberate the matter.
Since there was a blank period when waiting for the sponsor's response, the medical institution first had the new investigator prepare a list of subinvestigators and collaborators and submit it to the hospital director, who immediately nominated the hospital director. As for the change of investigator, we were asked not to deliberate on the matter until the sponsor submits the application for change, and we have not deliberated on the matter. Is this a good response?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 6 of the GCP, the sponsor is responsible for selecting the investigator. Therefore, even in emergency cases, the sponsor must select an appropriate investigator and apply to the head of the site for a change.
Generally, the selection procedure is defined in the company's SOP, and it takes time to obtain the CV of the new investigator, conduct an investigation, prepare records, and have them approved by the company manager. Only after these selection procedures are completed can the investigator and the new investigator agree on the investigative protocol, and then the application to the medical institution is permitted. In addition, notification of changes to the clinical trial plan based on the Pharmaceuticals and Medical Devices Law must be submitted prior to the conclusion of the MOU. Of course, in an urgent case such as this, these procedures must be completed promptly.
We believe that it is appropriate to hold an extraordinary meeting prepared by your hospital instead of a regular meeting to discuss the change of investigator. However, the sponsor may not be able to submit the documents to the IRB in time for an emergency IRB meeting due to the need to follow the procedures described above.
In addition, the procedure for the new investigator to prepare a list and obtain approval from the head of the site without any response from the sponsor may cause a discrepancy between the date of selection of the new investigator within the sponsor and the date of approval at your hospital.
Some parts of GCP require a series of procedures between the sponsor and the site. We recommend that you proceed with the procedures after thorough consultation with the sponsor, referring to the opinions in 2005-7, 2009-41, and 2009-43. In this case, all subjects have already completed their last visit to the hospital and all CRFs after SDV have been submitted. This is considered to be a special measure.
Reason for revision of opinion
Minor changes have been made to the description in accordance with the name change from the Pharmaceutical Affairs Law to the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Products.