Drug Evaluation Committee Requirements for Digitization of Paper Originals of Clinical Trial Documents (Focusing on the Operation of Certified Copy)
Electronic Information Subcommittee
April 2022
We are pleased to inform you that the deliverables of Task Force 3 (Certified Copy Team) of the Drug Evaluation Committee's Electronic Information Subcommittee for fiscal year 2021 are now available.
Task Force 3 of the Electronic Information Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) is continuing its efforts to promote the computerization of clinical trial-related documents.
With the increasing need for digitization of clinical trial-related documents, we have decided to hold a seminar for companies that are considering digitization of clinical trial-related documents, focusing on "creating electromagnetic records from paper media and managing them as Certified Copies," and to discuss the construction and operation of a Certified Copy management system based on the use of the eTMF system under the GCP domain. This document, "What is required for digitization of clinical trial-related documents (focusing on the operation of Certified Copy)," was prepared to show the items and points to be considered when establishing and operating a management system for Certified Copies.
We hope that this document will be of help to those who are working on the computerization of clinical trial-related documents and the spread of eTMF systems.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee 2021 Task Force 3
Deliverables of the Drug Evaluation Committee Return to list of all deliverables