Drug Evaluation Committee Common Master (Medical Institution-Related Information) for Utilization of Clinical Trial-Related Systems
Electronic Information Subcommittee
April 2024
In recent years, the use of various IT systems for the drug development process has spread rapidly, contributing greatly to improving the efficiency of clinical trials and the quality of data. However, the increase in the number of systems has also given rise to the problems of "information on medical institutions and physicians in clinical trials being managed separately in each system, resulting in duplication of maintenance and increased burden," and "slight gaps between systems hindering the utilization of information across systems.
We believe that this problem can be solved through the use of a master that can be shared by multiple systems (common master), and this report aims to encourage the creation and use of common masters by each company by delving into "a concrete image of the benefits of a common master and questions and countermeasures for creating a common master. The aim was to encourage the creation and use of a common master at each company. We hope that the results of this study will lead to discussions at each company and, ultimately, to the utilization of the system.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Electronic Information Subcommittee 2023 Task Force 3
All members of the Common Master Study Team
Deliverables of the Drug Evaluation Committee Return to list of all deliverables