Drug Evaluation Committee DM Transformation Topic "Data Flow and Ensuring Reliability in DCT
Data Science Subcommittee
August 2022
In response to major changes surrounding clinical trials, data flows have become more diverse and complex, and how to ensure the quality and reliability of data has become an urgent issue. Since the response to these issues is directly related to the ideal form of data management in the future, the Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee's Data Science Subcommittee Task Force 1 for FY2021 will focus on three topics under the theme of "DM Transformation: New Data Flow and Quality & Technology Assurance": "DDC/EHR Data Linkage DDC/EHR Data Linkage", "eSource and DCT", and "Efficient DM operations based on Fitness for Purpose".
This report summarizes the results of the study on "eSource and DCT.
As deliverables from JPMA on DCT, the Drug Evaluation Committee's Clinical Evaluation Subcommittee issued a report entitled "Study on the Introduction and Use of Clinical Trial Methods that Do Not Depend on Visits to Medical Institutions (September 2020)" and "Study on the This document follows on the heels of these documents and summarizes points to consider when introducing/operating DCT from the perspective of data management, with "ensuring data reliability" as one of the keywords.
We hope that this document will help companies that have not yet considered DCT, are considering, preparing to introduce, or have already introduced DCT to overcome current issues and move forward in some way.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee FY2021 TASF Force 1