Drug Evaluation Committee 2008-44 Timing of Notification of Changes to Clinical Trial Agreements Related to Changes in SMOs
Related classification: Clinical trial contract procedures
First published: 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 and Medical 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 change. 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 clinical trials in accordance with the protocol, it is required to notify the following within 6 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.
JPMA's Opinion
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 Agency Announcement No. 0831-10, August 31, 2020), it is required to notify the following items together with other post-notification information within 6 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) The following items may 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 and address of the party that is entrusted with all or part of the work related to the request and management of the clinical trial (Contract Research Organization (CRO)) and the scope of work to be entrusted" and "changes, additions and deletions of the name and address of the party that is entrusted with a part of the work related to the conduct of the clinical trial by Investigator Site (Clinical Research Organization (SMO)) The notification includes "changes in, additions to, and deletions from the names and addresses of contract research organizations (CROs), as well as changes in the scope of services entrusted to them by the sponsoring medical institution.
Reason for revision
The description has been updated in accordance with the revision of the notice on clinical trial notification.