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 in the clinical trial environment, and how to ensure data quality and 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, Data Science Subcommittee, Task Force 1 for FY2021 will discuss three topics, "Transformation of DM: New Data Flow and Quality Assurance," under the theme of "Transformation of DM: New Data Flow and Quality Assurance," "DDC/EHR Data Collaboration," and "Data Quality and Reliability Assurance. 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 Data Science Subcommittee of the Pharmaceutical Manufacturers Association of Japan 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, Committee on Drug Evaluation
DS Subcommittee 2021 Task Force 1
Deliverables of the Drug Evaluation Committee Return to list of all deliverables