Drug Evaluation Committee 2021-16 Location of Investigational Drug Administration File
Related classification: Record keeping
First published: Aug. 2021
Question
I have a question regarding the storage location of investigational drug control files (documents prepared and stored to show that investigational drugs are properly controlled as described in Article 39 Guidance 4 of the GCP).
At the site where I am conducting clinical trials, the investigational new drug control file has been stored together with the investigational new drug on the storage shelf in the pharmacy department. However, the pharmacy asked us to store the investigational new drug files on the shelves of each SMO because the storage space became too tight.
The drugs were kept on the shelves of the Pharmacy Department, and the files were kept on the shelves of the SMO in the Clinical Trial Management Office next to the Pharmacy Department (the SMO managed the shelves and controlled the keys), resulting in a situation where the SMO managed the files.
We explained to the Pharmacy Department that the file is managed by the investigational drug manager and contains documents related to investigational drug management, such as the investigational drug management protocol, and therefore must be stored together with the investigational drug in the Pharmacy Department, but this was understood as "idealistic". The SOP at the site does not include a record of storage of investigational drug management files, and the contract between the site and each SMO states "assistance with investigational drug management (checking medication status and remaining drug quantities, delivery and return, and record storage)," and I thought that record storage might fall under that category.
Am I wrong in understanding that "both the investigational new drug and the investigational new drug management file are kept together? Or is it correct to say that each SMO stores the investigational new drug in consideration of the situation in the pharmacy department of the site?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Your question is correct in that both the investigational new drug and the investigational new drug management file should be stored together. < p/>
On the other hand, there may be cases where the investigational new drug and the investigational new drug management file cannot be stored in the same place due to physical problems such as storage space for materials. The concept of such cases is described below.
In terms of record retention, Article 41, Paragraph 2, Guidance 2 of the GCP stipulates that "the head of the site or the person responsible for record retention shall 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. The specific storage method for these measures should be in accordance with the procedures of the site.
In addition, from the viewpoint of the performance of duties by the investigational drug administrator/assistant, the contents stipulated in Article 39 of the GCP must be in a state where they can be performed in a timely and appropriate manner.
In this case, if the investigational new drug administrator/assistant can access the file at any time when performing his/her duties, and if necessary measures can be taken to ensure a secure location where the file cannot be easily accessed by third parties, lost, or destroyed, then each SMO can store the investigational new drug administration file based on the outsourcing agreement with the site and the SMO can provide the file to the investigational new drug administrator/assistant in a timely and appropriate manner. If it is possible to take necessary measures to ensure a secure location that is not easily accessible by a third party and is not lost or destroyed, there should be no problem with each SMO storing investigational new drug management files based on the outsourcing agreement with the site.