Drug Evaluation Committee DM Transformation Topic "Efficient DM Operations Based on Fitness for Purpose
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 data quality/reliability 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 discuss three topics under the theme of "Transformation of DM: 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 "Efficient DM Operations Based on Fitness for Purpose.
This document is based on the Society for Clinical Data Management's Reflection papers "The Evolution of Clinical Data Management to Clinical Data Science" (introduced at the JPMA's Data Science Subcommittee). The book summarizes current information and case studies focusing on three of the new elements required for the future vision of data managers as outlined in the Society for Clinical Data Management's Reflection paper "The Evolution of Clinical Data Management to Clinical Data Science" (released in April 2021): risk-based approaches, new data review methods, and automation (survey and case study introduction), We believe that this will lead to more efficient DM operations.
While new concepts, regulatory requirements, and new technologies are expected to change the future of data management, we hope that this publication will serve as a stepping stone toward the evolution of data managers.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee FY2021 TASF Force 1