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  • Title
    Integrated data management for clinical studies: Automatic transformation of data models with semantic Annotations for Principal Investigators, Data Managers and Statisticians
  • Author
    Dugas, Martin ; Dugas-Breit, Susanne
  • Published
    28/02/2014
  • Annotation
    Finanziert durch den Open-Access-Publikationsfonds 2013/2014 der Deutschen Forschungsgemeinschaft (DFG) und der Westfälischen Wilhelms-Universität Münster (WWU Münster).
  • Language
    English
  • Bibl. Reference
    PLoS ONE 9 (2014) 2, e90492
  • Document type
    Journal Article
  • URN
    urn:nbn:de:hbz:6-83389563328 
  • DOI
    doi:10.1371/journal.pone.0090492 
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  •  The document is publicly available on the WWW
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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.
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