title: Standardized terminology for clinical trial protocols based on top-level ontological categories.
abstract: This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.
authors.affiliation: Institute for Medical Informatics, Statistics and Epidemiology, University of Leipzig, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Heller
authors.forename: H
authors.initials: H
authors.lastname: Herre
authors.forename: K
authors.initials: K
authors.lastname: Lippoldt
authors.forename: M
authors.initials: M
authors.lastname: Loeffler
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D006801:Humans; D011785:Quality Assurance, Health Care; D012984:Software; D009626:Terminology as Topic