The Ontology of Clinical Research (OCRe): An informatics foundation for the science of clinical research

Ida Sim, Samson W. Tu, Simona Carini, Harold P. Lehmann, Bradley H Pollock, Mor Peleg, Knut M. Wittkowski

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes - the science of clinical research - are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe's modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study's scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research.

Original languageEnglish (US)
Pages (from-to)78-91
Number of pages14
JournalJournal of Biomedical Informatics
Volume52
DOIs
StatePublished - Dec 1 2014
Externally publishedYes

Fingerprint

Informatics
Ontology
Research
Network protocols
Semantics
Technology
Computer simulation

Keywords

  • Clinical research
  • Clinical research informatics
  • Eligibility criteria
  • Evidence-based medicine
  • Ontology
  • Trial registration

ASJC Scopus subject areas

  • Computer Science Applications
  • Health Informatics
  • Medicine(all)

Cite this

The Ontology of Clinical Research (OCRe) : An informatics foundation for the science of clinical research. / Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Bradley H; Peleg, Mor; Wittkowski, Knut M.

In: Journal of Biomedical Informatics, Vol. 52, 01.12.2014, p. 78-91.

Research output: Contribution to journalArticle

Sim, Ida ; Tu, Samson W. ; Carini, Simona ; Lehmann, Harold P. ; Pollock, Bradley H ; Peleg, Mor ; Wittkowski, Knut M. / The Ontology of Clinical Research (OCRe) : An informatics foundation for the science of clinical research. In: Journal of Biomedical Informatics. 2014 ; Vol. 52. pp. 78-91.
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