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"
Data Science Subcommittee
April 2021
Clinical trials are undergoing a revolution in study design and the technology that can/should be utilized is evolving. In addition, regulatory aspects and the quality required in clinical trials are becoming more diverse in terms of what needs to be considered and what needs to be resolved.
In light of the above, the Society for Clinical Data Management (SCDM) has released a Reflection The Evolution of Clinical Data Management to Clinical Data Science" Part 1 (June 2019), Part 2 (March 2020), and Part 3 (August 2020). The introduction of Part 1 and Part 2 was already released in November 2020, and this edition is structured to cover the entire Reflection paper by adding the introduction of Part 3 in the second half.
This document is a slide-based publication that focuses solely on the introduction of the SCDM Reflection papers, with the aim of releasing it as soon as possible under the circumstances where changes in data management are expected in the wake of COVID-19. JPMA's views are not included in this document, and we are planning a separate TF activity to discuss specific issues and measures to address them.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee FY2020 Task Force 2
Innovative Changes in Data Management (full version) (18.7MB)