Drug Evaluation Committee Requirements for Digitization of Paper Originals of Clinical Trial Documents (Focusing on Operation of Certified Copy)
Electronic Standard for Medical Information Expert Committee
April 2022
Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeWe are pleased to inform you that the 2021 deliverables of Task Force 3 (Certified Copy Team) have been posted.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 3 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 focusing on "creating electromagnetic records from paper media and managing them as Certified Copies" for companies that are considering digitization of clinical trial-related documents, and to provide information on the construction and operation of a Certified Copy management system based on the use of eTMF systems 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 Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee 2021 Task Force 3