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W-02: Healthcare Link Project in Japan: Development of a New Seamless Data Stream from EHR to EDC System Using SS-MIX2 Storages





Poster Presenter

      Kiyoteru Takenouchi

      • CDISC Program Coodinator, Translational Research Informatics Center (TRI)
      • Foundation for Biomedical Research and Innovation (FBRI)
        Japan

Objectives

Explain how we tried to resolve the complexities associated with EHR to EDC data transfer, emerging seamless data streams from EHR to EDC system, the important role of CDISC Standards, ongoing clinical study on diabetes and discuss the impact of our system on clinical studies.

Method

We developed a new system which is independent from not only EHR vendors but also EDC vendors by using SS-MIX2 (Standardized Structured Medical Information eXchange) Standardized Storage, an electronic “EMR stamp” which can be on progress note s of EHR and RFD (Retrieve Form for Data Capture)

Results

SS-MIX2 Standardized and Annex Storages are nationwide standard in Japan. Under the circumstances that medical sites can choose any EHR vendors they like, it is necessary to overcome the complexities associated with the data transfer from EHR to EDC. They make it difficult to use the data in EHR for clinical studies especially conducted in multiple sites. We developed a new system which is independent from not only EHR vendors but also EDC vendors by using SS-MIX2 Standardized Storage and an electronic “EMR stamp” which can be on progress notes of EHR. It is very important to standardize and harmonize clinical studies in a specific disease area to improve data quality and faster the completion of clinical studies. In our clinical study on diabetes, the data have been collected according to the protocol which was drawn on the concept of CDISC TAS (Therapeutic Area Standards) for diabetes developed by CFAST (The Coalition for Accelerating Standards and Therapies). The collected data were converted to CDASH (Clinical Data Acquisition Standards Harmonization) – ODM (Operational Data Model) format and transferred to our internally developed EDC system. We used RFD (Retrieve Form for Data Capture) which was developed by CDISC and IHE (Integrating the Healthcare Enterprise) as the platform of the system.

Conclusion

SS-MIX2 Standardized and Annex Storages are nationwide standard in Japan. Under the circumstances that medical sites can choose any EHR vendors they like, it is necessary to overcome the complexities associated with the data transfer from EHR to EDC. They make it difficult to use the data in EHR for clinical studies especially conducted in multiple sites. We developed a new system which is independent from not only EHR vendors but also EDC vendors by using SS-MIX2 Standardized Storage and an electronic “EMR stamp” which can be on progress notes of EHR and made seamless data streams from EHR to EDC system in practice. We have just started collecting patient demographics, disease classifications, prescriptions and lab results not only on the visit day defined in the protocol, but whenever the patients are taken care of in the sites. All the patients’ data from their daily medical practice during the study period transferred from EHR to EDC system have become are available as data for analyses. It has become possible to conduct clinical studies with improved data quality and faster the completion of clinical studies. Additional authors: Mr. Keisuke Yuasa and Mr. Masahiro Shioya Co-author: Dr. Hiroshi Watanabe (Hamamatsu University School of Medicine)