Drug Evaluation Committee 2011-38 Notification of Discontinuation of Development or Clinical Trial after Investigator Site Closure/Marketing Authorization
Related classification: Record keeping
First published: Apr. 2012
Question
A clinical trial that was being conducted at an Investigator Site was reported as terminated in October 2010. In January 2012, the sponsor of the Investigator Site contacted the SMO (us) with a request to issue a "Report on Discontinuation of Development".
In this case, how should the name of the Investigator Site (address) be written?
JPMA's Opinion
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.