Drug Evaluation Committee May 2016: Retention of Subject Registration and Investigational Drug Assignment Records
Related Category: Record Retention
Initial Publication Date: June 2016
Revised Publication Date: April 2024
Question
In recent global clinical trials, there has been an increasing trend toward using IXRS (IVRS/IWRS) for subject enrollment and investigational drug allocation.Both the Investigator Site and the sponsor receive notifications regarding enrollment and investigational drug assignment via email; however, the sponsor has instructed us that these emails must be printed out and
retained as mandatory documents. I questioned whether it is necessary to go to the trouble of printing out and storing documents received electronically (via email) as mandatory documents.
Opinion of the JPMA
Records documenting the process of subject enrollment and investigational drug allocation must be retained as source documents necessary for reconstructing the factual course of the clinical trial. When such records are received via email, the recipient must determine the method of retention; printing and storing the email is considered one such method.
JPMA has published documents such as the “Standard Operating Procedures for the Digitization of Clinical Trial Procedures for Medical Institutions”*1 as guidelines for implementing clinical trial procedures that utilize electronic records.Furthermore, in Section 5.5, “Delivery and Receipt of Electronic Records (2) When Using Email, 2) Upon Receipt,” of these SOPs, the following procedure is outlined: “As records for verifying the factual sequence of events, save the received email and any reply emails, or create a receipt log to record the recipient, date of receipt, and content of the message.Furthermore, in the event of receipt on behalf of another party, the recipient must promptly contact the intended recipient and maintain records so that the sequence of events confirmed by the intended recipient can be verified.”
In this instance, we understand that the clinical trial sponsor has requested that printed copies of emails be retained as mandatory documents. Regarding the method for retaining received emails, depending on the circumstances at each Investigator Site, options include retaining printed copies of received emails, creating and retaining a logbook (recording the recipient, date of receipt, content of the message, etc.),or storing the received emails electronically (in the case of electronic storage, authenticity, legibility, and durability must be ensured in accordance with the Japanese ER/ES Guidelines). We therefore recommend discussing the storage method with the clinical trial sponsor.