Drug Evaluation Committee 2021-16 Location of Investigational Drug Administration File
Related classification: Record keeping
First published: August 2021
Question
I have a question about 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 Investigator Site where I am conducting clinical trial operations, the investigator files have been stored together with the investigational drug in the storage cabinet of the Pharmacy Department. However, the pharmacy department requested that the investigational new drug files be stored on the shelves of each SMO due to storage space constraints.
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 investigational drug management 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 Investigator Site's SOP does not include a record of the storage of investigational drug management files, and the contract between the Investigator Site and each SMO states "assistance with investigational drug management (checking medication status and remaining drug quantities, delivery and return, and record keeping)," and I thought that record keeping would 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 should store them in consideration of the status of the Investigator Site's pharmacy department?
JPMA's Opinion
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 states that "The head of the Investigator 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 are available upon request. However, the specific storage method for these measures is to be in accordance with the procedure manual of the Investigator 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 it is possible to take the necessary measures to ensure that the investigator site manager and assistants can access the file at any time when performing their duties, and that the file is not easily accessible by third parties, and that it is in a safe place where it cannot be lost or destroyed, then each SMO should store the investigator site management file based on the outsourcing agreement with the Investigator Site. 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.