Drug Evaluation Committee 2015-08 Storage Locations for Required Documents
Related classification: Record keeping
Date of first publication: August 2015
Question
We are planning to set up a clinical trial office in the Pharmaceutical Department. In this case, from the perspective of essential document storage, are there any provisions for facilities such as "a lockable room partitioned off by a wall"? The pharmacy itself is to be locked at night and when not in the office. In addition, essential documents are stored in a locked cabinet.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 41, Paragraph 2, Guidance 2 of the GCP, "The head of the implementing medical institution or the person responsible for record keeping must take necessary measures to ensure that these records are not lost or destroyed during the mandatory retention period, and that they can be presented upon request. However, there are no specific provisions regarding these measures.
Therefore, when storing records by the implementing medical institution, there is no problem in taking necessary measures to secure a secure location that is not easily accessible by a third party and cannot be lost or disposed of.