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.
JPMA's Opinion
Article 41, Paragraph 2, Guidance 2 of the GCP stipulates that "the head of the Investigator Site or the person in charge of record keeping shall take necessary measures to ensure that these records are not lost or destroyed during the period of this retention obligation and that they are available upon request. However, there are no specific provisions regarding these measures.
Therefore, when records are stored by Investigator Site, there is no problem in taking necessary measures to ensure a secure location that is not easily accessible by third parties and cannot be lost or destroyed.