Drug Evaluation Committee (8) Termination of Provision of Safety Information by the Sponsor (Part 1)
Related classification: clinical trial contracting procedures
First published: December 2004
Revised publication date: March 2021
Question
The hospital sets the deadline for accepting reports of safety information until the completion report of the sponsored research is submitted. In cases where the clinical trial itself has actually been completed but the termination report has not yet been submitted, the safety report is accepted and handled by the secretariat. Since this is a time-consuming task for the secretariat, we are considering the possibility of setting a different time frame, such as until the end of the contract. I have not seen anything that clearly states when the deadline for acceptance is. I would appreciate it if you could give me your opinion as to when it is appropriate under GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
According to Article 20 of GCP, the sponsor must notify and provide the investigator and the head of the institution with information on adverse drug reactions, etc. (hereinafter referred to as "safety information") related to the investigational drug. However, there is no regulation on how long the safety information must be provided continuously. Therefore, there may be some differences among sponsors in the handling of such information. However, the purpose of GCP Article 20 is to prevent the spread of adverse health effects caused by investigational drugs by ensuring that the sponsor provides the most up-to-date safety information to the investigator and the head of the institution and pays close attention to ensuring the safety of subjects during the trial period. For this reason, we believe that the sponsor should continue to provide safety information at least until the completion of administration and observation as stipulated in the study protocol. Therefore, it is up to each site to decide whether or not to provide safety information after that time.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.