Drug Evaluation Committee 2011-38 Notification of Discontinuation of Development or Clinical Trial after Closure of a Performing Medical Institution/Marketing Authorization
Related classification: Record keeping
Date of first publication: Apr. 2012
Question
A clinical trial that was being conducted at a certain medical institution was reported as terminated in October 2010. In January 2012, the sponsor of this clinical trial contacted the SMO (us) with a request to issue a "Report on Discontinuation of Development".
In this case, how should the name of the site (destination) be indicated?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The medical institution that conducted the clinical trial is obligated to preserve the records of the trial in accordance with the provisions of Article 40 of the GCP. In the case of closure of a hospital, it is necessary for another medical institution or the SMO that provided operational support to take over the preservation duties of the clinical trial documents related to the trial.
Therefore, it would be appropriate to notify the head of the medical institution or the representative of the SMO, etc. that has taken over this task, stating that this is a matter related to clinical trial-related documents that have been taken over from the closed medical institution.