Drug Evaluation Committee Overview of eSource (DDC and EHR) and points to keep in mind when implementing eSource (DDC and EHR)
April 2020
In recent years, with the widespread adoption of EDC (Electronic Data Capture), pharmaceutical companies have been able to manage clinical trial data more efficiently.On the other hand, medical institutions are now required not only to record patients’ clinical information in medical records but also to enter clinical trial data into EDC systems. To further ensure quality and improve operational efficiency, they have begun exploring methods to extract clinical trial data directly from electronic medical records into EDC systems without manual intervention.In the United States and Europe, regulatory authorities have issued guidelines and other documents, and regulatory frameworks for the use of eSource (Electronic Source) in clinical trials are being developed. In Japan as well, some companies have begun conducting trials using DDC (Direct Data Capture).Task Force 1 of the Data Science Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) focused on DDC and EHR (Electronic Health Records) to assess the current status of eSource and conducted a survey of member companies regarding the implementation status and environment for processes to acquire data from DDC and EHR.This report presents the survey results and provides an overview of DDC along with key considerations for its implementation.
Please note that the scope of this report is limited to industry-sponsored clinical trials (Phases 1 through 4); other types of clinical research are excluded.
We hope this report will contribute to the adoption of eSource in the pharmaceutical industry.
Overview of eSource (DDC and EHR) and Considerations for Implementation (1.1MB)