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A Metadata Extraction Approach for Clinical Case Reports to Enable Advanced Understanding of Biomedical Concepts
Published on: September 20, 2018
Integrated data management for clinical studies: automatic transformation of data models with semantic annotations
Martin Dugas1, Susanne Dugas-Breit2
1Institute of Medical Informatics, University of Münster, Münster, Germany.
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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