Integrated data management for clinical studies: automatic transformation of data models with semantic annotations for principal investigators, data managers and statisticians

PLoS One. 2014 Feb 28;9(2):e90492. doi: 10.1371/journal.pone.0090492. eCollection 2014.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Biomedical Research / methods
  • Biomedical Research / statistics & numerical data*
  • Humans
  • Information Storage and Retrieval / methods*
  • Internet
  • Medical Informatics Computing / statistics & numerical data
  • Medical Records Systems, Computerized / statistics & numerical data*
  • Reproducibility of Results
  • Research Personnel*
  • Software

Grants and funding

The authors acknowledge financial support by Deutsche Forschungsgemeinschaft and Open Access Publication Fund of University of Muenster. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No additional external funding was received for this study.