Drug Evaluation Committee 2012-50 Materials that must be retained after the expiration of the retention period under GCP
Related classification: Record keeping
First published: March 2013
Question
We have been burning materials after receiving a notice from the sponsor that the retention period for essential clinical trial documents has expired. For example, we would like to know what kind of materials such as contracts and study protocols should be kept as they will help us understand what kind of clinical trial it is later on.
Since they are confidential information, I wonder if the sponsor wants to burn all the materials after the retention period has expired.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Unless otherwise specified in the contract with the sponsor, the retention period for documents and records related to a clinical trial is the period specified in Article 41, Paragraph 2 of the GCP. Therefore, there is no problem under GCP if all documents and records pertaining to the relevant clinical trial are disposed of upon receipt of a notification from the sponsor that the retention period has expired.
In accordance with other laws and regulations as well as the procedures and policies of the investigational institution, there is no problem with retaining the relevant documents and records after the end of the retention period stipulated in the GCP or clinical trial agreement, but it is necessary to maintain the confidentiality of the subject drug and clinical trial in accordance with the agreement.