Drug Evaluation Committee Current Status and Issues of DDC/EHR Data Linkage
Data Science Subcommittee
September 2022
The flow of data has become more diverse and complex in response to major changes surrounding clinical trials, 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's Data Science Subcommittee Task Force 1 for FY2021 will focus on three topics under the theme of "DM Transformation: 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 "DDC/EHR Data Linkage.
Overview of eSource (DDC and EHR) and Points to Consider when Introducing eSource (DDC and EHR)" was released by the JPMA Data Science Subcommittee in March 2020 as a deliverable regarding the use of DDC (Direct Data Capture) and EHR (Electronic Health Record) data for clinical trials. This document is a follow-up to this document.
This document is a follow-up to this document, which identifies the degree of penetration and changes in the use of DDC and EHR data for clinical trials within the pharmaceutical industry, including CROs and medical institutions, in FY 2019 and beyond, and proposes issues and measures for further promotion of the use of DDC and EHR data.
We hope that this publication will encourage the pharmaceutical industry to improve the efficiency and speed of clinical trials.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
DS Subcommittee 2021 Task Force 1