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

• Published in: PloS one Vol. 9; no. 2; p. e90492
• Main Authors: Dugas, Martin, Dugas-Breit, Susanne
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 28.02.2014; Public Library of Science (PLoS)
• Subjects: Annotations; Automation; Biology; Biomedical Research - methods; Biomedical Research - statistics & numerical data; Cancer; Clinical trials; Codes; Computer Science; Data analysis; Data capture; Data management; Data models; Design; Format; Freeware; Humans; Informatics; Information Storage and Retrieval - methods; Internet; Interoperability; Jargon; Medical Informatics Computing - statistics & numerical data; Medical Records Systems, Computerized - statistics & numerical data; Medical research; Medicine; Metadata; Methods; Reproducibility of Results; Research Personnel; Semantics; Software; Statistical analysis; Studies; Terminology; Transformation; Values
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0090492

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.