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Résumé

Electronic Data Capture (EDC) software solutions are progressively being adopted for conducting clinical trials and studies, carried out by biomedi-cal, pharmaceutical and health-care research teams. In this paper we present the MedRed Ontology, whose goal is to represent the metadata of these studies, using well-established standards, and reusing related vocabularies to describe essential aspects, such as validation rules, composability, or provenance. The paper de-scribes the design principles behind the ontology and how it relates to existing models and formats used in the industry. We also reuse well-known vocabularies and W3C recommendations. Furthermore, we have validated the ontology with ex-isting clinical studies in the context of the MedRed project, as well as a collection of metadata of well-known studies. Finally, we have made the ontology available publicly following best practices and vocabulary sharing guidelines.

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