Drug Evaluation Committee 2024-23 Electromagnetic Records Using Clinical Trial Cloud System

Related classification: Others

Date of first publication: October 2024

Question

I have a question regarding electromagnetic records using the Clinical Trial Cloud System.
The "Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents" prepared by the Pharmaceutical Manufacturers Association of Japan (PMAJ) states that electromagnetic records using the Clinical Trial Cloud System are to be used as "records for verifying the factual process" in the operation log of the system.
In order to comply with the above process, some sponsors are required to store screenshots of screens delivered/received on the Trial Cloud System and extracted data from the system logs in the TMF as a record of the process of delivery/receipt.
Is it the intent of the Pharmaceutical Manufacturers Association to require "records for verifying the factual process" to be stored in the TMF as the sponsor's records?
We believe that there should be no problem as long as the factual process can be verified from the operation logs in the system, since it has been introduced after confirming that there are no problems with the electromagnetic checklist in terms of authenticity, readability, retention, backup and recovery.
Many sponsors do not require "records for verifying the factual process" to be stored in the TMF, so we would appreciate it if you could confirm whether this is the view of the Pharmaceutical Manufacturers Association or not.

The following is an excerpt from the Standard Operating Procedures for Electromagnetic Handling of Clinical Trial Documents (2024 version) (for sponsors)
5.4 Delivery and receipt of electromagnetic records
Delivery or receipt of an electromagnetic record is defined as storing the electromagnetic record in the clinical trial cloud system and notifying the other party of the delivery or confirming that the other party has viewed or downloaded the electromagnetic record by using the operation log. The operation log of the system is used as a "record for verifying the factual process.
In the case of delivery and receipt using other cloud systems, the fact should be recorded in such a way that the process can be verified (e.g., by using an e-mail notifying the delivery and receipt).

Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)

　As you understand, the system validation should be conducted to ensure that the requirements for using the clinical trial cloud system (e.g., that audit trails for creation, modification, deletion, viewing, and downloading are recorded; that the readability, preservation, and integrity of electromagnetic records are ensured; and that backup and recovery procedures are documented) and that the system is used when necessary. The operation log of the clinical trial cloud system can be used as a "record for verifying the factual process" if it is confirmed that the system log can be accessed when necessary, and that screenshots of screens delivered/received on the clinical trial cloud system and extracted data from the system log can be used as a "record for verifying the factual process". It is not assumed that screen shots of screens delivered/received on the clinical trial cloud system or extracted data from the system logs will be stored in TMF as "records for verifying the factual process". In actual operation, please consult with the sponsor as necessary in light of the system functions, period of use, method and scope of transferring electromagnetic records (including audit trails) to the sponsor after the completion of the study, and the standard operating procedures of each company.

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