Drug Evaluation Committee 2008-44 Timing of Notification of Changes to Clinical Trial Agreements Related to Changes in SMOs
Related classification: clinical trial contracting procedures
Initial release date: Mar. 2009
Revised publication date: Mar. 2021
Question
We believe that the names and addresses of CROs and SMOs and the scope of services they are entrusted with must be notified for each clinical trial protocol. However, a certain sponsor has informed us that according to the Pharmaceutical Affairs Bureau's Notification No. 0831-10 dated August 31, 2020, it is acceptable to notify "changes, additions and deletions to the names, addresses and scope of contracted services of CROs and SMOs" together within 6 months after the changes are made. Therefore, if the names and addresses of CROs and SMOs and the scope of contracted services are notified for the first time for Phase I trials or for the first time thereafter, for subsequent trials in accordance with the clinical trial protocol, it is required to notify the following within six months from the date of change or addition of CROs and SMOs (or from the date of notification of the clinical trial plan in the clinical trial protocol) We have been informed that it is sufficient to submit a notification of changes to the clinical trial plan regarding the names and addresses of the CRO and SMO and the scope of services to be entrusted. We have doubts as to whether this is really a good idea. Please let us know if the decision of a certain clinical trial sponsor is acceptable or not.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to the "Handling of Notification of a Clinical Trial Plan for a Drug by a Person Who Wants to Request a Clinical Trial" (NHI Drugs and Pharmaceuticals Agency Announcement No. 0831-10, August 31, 2020), it is not required to submit a notification together with other post-notification information within six months after the change (not from the date of notification of the clinical trial plan, but from the date of change of the relevant information) as a rule. The following items can be notified together with other post-notification information within 6 months after the change (not from the date of notification of the clinical trial plan): "changes, additions, and deletions of the name, address, and the scope of work entrusted to a contract research organization (CRO) that is entrusted with all or part of the work related to the request and management of a clinical trial" and "names, addresses, and entrustment of a person who is entrusted by a clinical trial site support organization (SMO) with a part of the work related to the conduct of a clinical trial. (CROs), and "Changes, additions, and deletions to the name, address, and scope of services entrusted by the site management organization (SMO)".
Reason for revision of opinion
The description has been updated in accordance with the revision of the notice on clinical trial notification.