Drug Evaluation Committee DM Transformation Topic "Data Flow in DCT and Ensuring its Reliability
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, Data Science Subcommittee, Task Force 1 for FY2021 will discuss three topics, "Transformation of DM: New Data Flow and Quality Assurance," under the theme of "Transformation of DM: New Data Flow and Quality Assurance," "DDC/EHR Data Linkage," and "Data Quality and Reliability Assurance. 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".
The deliverables from the Pharmaceutical Manufacturers Association on DCT include "Study for the introduction and utilization of clinical trial methods that do not depend on visits to medical institutions (September 2020)" from the Clinical Evaluation Committee of the Drug Evaluation Committee, "Study for the introduction and utilization of clinical trial methods that do not depend on visits to medical institutions. 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 their current issues and move forward in some way.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
DS Subcommittee 2021 TASF Force 1
Deliverables of the Drug Evaluation Committee Return to list of all deliverables