• Stud Health Technol Inform · Jan 2011

    The single source architecture x4T to connect medical documentation and clinical research.

    • Philipp Dziuballe, Christian Forster, Bernhard Breil, Volker Thiemann, Fleur Fritz, Jens Lechtenbörger, Gottfried Vossen, and Martin Dugas.
    • Department of Medical Informatics, University of Münster, Germany. philipp.dziuballe@ukmuenster.de
    • Stud Health Technol Inform. 2011 Jan 1; 169: 902-6.

    AbstractClinical trials often require large and redundant documentation efforts, because information systems in patient care and research are separated. In two clinical trials we have assessed the number of study items available in the clinical information system for re-use in clinical research. We have analysed common standards such as HL7, IHE RFD and CDISC ODM, regulatory constraints and the documentation process. Based on this analysis we have designed and implemented an architecture for an integrated clinical trial documentation workflow. Key aspects are the re-use of existing medical routine data and the integration into current documentation workflows.

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