Drug Evaluation Committee 2015-29 Bulk Filing of Records to be Kept by Clinical Investigators and the Head of the Operating Medical Institution (Part 2)
Related classification: Record keeping
Date of first publication: February 2016
Question
The sponsor has requested that the following documents, which were previously kept by the investigator, not be kept for the purpose of reducing the volume of files.
- Safety line list
- Individual Case Form
Since the secretariat is storing these documents for the hospital director, we are wondering if it would be okay to delete them from the investigator's files, but is there any problem with this under GCP? If the investigator wants to know the information on the line list, he/she can access the documents stored by the hospital director.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
It is important that the investigator be able to access each record promptly when necessary during the clinical trial period. If a system can be established to fulfill this condition, there is no problem in appointing a person responsible for keeping each record, organizing the documents, and storing them in a reasonable manner. Please also refer to our previous opinion (2010-38).
In addition, it is recommended to record the history of retention of only one of the materials (and disposal of the other) in order to indicate to a third party that the head of the investigational site and the investigator each receive the materials provided by the sponsor.