Drug Evaluation Committee Overview of eSource (DDC and EHR) and Points to Consider When Introducing eSource
Data Science Subcommittee
April 2020
In recent years, with the spread of EDC (Electronic Data Capture), it has become possible for pharmaceutical companies to quickly manage data related to clinical trials. On the other hand, medical institutions are now required not only to record subjects' medical information in medical records but also to input data related to clinical trials into EDC. In the U.S. and Europe, the method of obtaining clinical trial data directly from electronic medical record information to EDC has been considered. In the U.S. and Europe, regulatory authorities have issued guidelines and other guidelines, and regulations are being developed for the use of electronic sources (eSources) in clinical trials. In Japan, some companies have experienced 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 Healthcare Record) to understand the current status of eSource, and conducted a questionnaire survey of member companies regarding the status of implementation of processes and environment for data acquisition from DDC and EHR. This report presents the results of the survey. This report presents the results of the survey, as well as an overview of DDC and points to keep in mind when implementing DDC.
The scope of this report covers company-initiated clinical trials (Phase 1 to Phase 4) and does not cover other clinical research.
We hope that this report will help the pharmaceutical industry to utilize eSource.
Overview of eSource (DDC and EHR) and points to keep in mind when implementing (1.1MB)
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