Drug Evaluation Committee DM Transformation Topic "Efficient DM Operations Based on Fitness for Purpose
August 2022
In light of major changes in the clinical trial landscape, data flows have become increasingly diverse and complex, making the assurance of data quality and reliability an urgent priority.Since addressing these challenges is directly linked to the future of data management, the FY2021 Task Force 1 of the Data Science Subcommittee under the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) examined three topics—“DDC/EHR Data Integration,”, “eSource and DCT,” and “Efficient DM Operations Based on Fitness for Purpose.”
This report summarizes the findings from the discussion on “Efficient DM Operations Based on Fitness for Purpose.”
This report focuses on three new elements required to achieve the future vision for data managers outlined in the Society for Clinical Data Management’s Reflection Papers, “The Evolution of Clinical Data Management to Clinical Data Science” (presentation materials released by the JPMA Data Science Subcommittee in April 2021):—“risk-based approach,” “new data review methods,” and “automation (surveys and case studies)”—and compiles current information and case studies. We believe this will also contribute to streamlining current DM operations.
While the vision itself is expected to evolve due to new concepts, additional regulatory requirements, and the introduction of new technologies, we hope this document will serve as a stepping stone toward the evolution of data managers.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee,
, DS Subcommittee, FY2021 Task Force 1