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Integrated Data Management for Clinical Studies: Automatic Transformation of Data Models with Semantic Annotations for Principal Investigators, Data Managers and Statisticians

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  • Martin Dugas
  • Susanne Dugas-Breit

Abstract

Design, execution and analysis of clinical studies involves several stakeholders with different professional backgrounds. Typically, principle investigators are familiar with standard office tools, data managers apply electronic data capture (EDC) systems and statisticians work with statistics software. Case report forms (CRFs) specify the data model of study subjects, evolve over time and consist of hundreds to thousands of data items per study. To avoid erroneous manual transformation work, a converting tool for different representations of study data models was designed. It can convert between office format, EDC and statistics format. In addition, it supports semantic annotations, which enable precise definitions for data items. A reference implementation is available as open source package ODMconverter at http://cran.r-project.org.

Suggested Citation

  • Martin Dugas & Susanne Dugas-Breit, 2014. "Integrated Data Management for Clinical Studies: Automatic Transformation of Data Models with Semantic Annotations for Principal Investigators, Data Managers and Statisticians," PLOS ONE, Public Library of Science, vol. 9(2), pages 1-5, February.
    • Handle: RePEc:plo:pone00:0090492
    DOI: 10.1371/journal.pone.0090492
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