Drug Evaluation Committee Innovative Changes in Data Management (Full Version) Introduction to SCDM Reflection papers "The Evolution of Clinical Data Management to Clinical Data Science"
April 2021
Clinical trials are undergoing a transformation in trial design, and the technologies that can and should be utilized are evolving. Furthermore, the range of considerations and challenges that must be addressed—such as regulatory requirements and the quality standards demanded in clinical trials—is becoming increasingly diverse.
In light of the above, as a clinical trial data manager, the following Reflection Papers released by the Society for Clinical Data Management (SCDM) provide essential information for organizing and understanding the required skill set, the roles to be fulfilled, and the future vision to strive for: “The Evolution of Clinical Data Management to Clinical Data Science”—Part 1 (June 2019), Part 2 (March 2020), and Part 3 (August 2020)—released by the Society for Clinical Data Management (SCDM).Note that introductions to Parts 1 and 2 were already released in November 2020; this document adds an introduction to Part 3 in the latter half to provide a comprehensive overview of the entire Reflection Paper series.
This document is a slide-based publication dedicated solely to introducing the SCDM Reflection Papers, released promptly to address the urgent need for transformation in data management amid the impact of COVID-19. The views of the JPMA are not included in this document; separate task force (TF) activities are planned to discuss specific challenges and countermeasures.
Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee
Data Science Subcommittee FY2020 Task Force 2
Innovative Changes in Data Management (Full Version) (18.7MB)