Norme internationale
ISO 14199:2015
Informatique de santé — Modèle d'information — Modèle de groupe de domaine intégré de recherche biomédicale (BRIDG)
Numéro de référence
ISO 14199:2015
Edition 1
2015-09
Norme internationale
Prévisualiser
ISO 14199:2015
66767
Indisponible en français
Publiée (Edition 1, 2015)
Cette norme a été révisée et confirmée pour la dernière fois en 2021. Cette édition reste donc d’actualité.

ISO 14199:2015

ISO 14199:2015
66767
Langue
Format
CHF 63
Convertir les francs suisses (CHF) dans une autre devise

Résumé

ISO 14199:2015 defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model for use in supporting development of computer software, databases, metadata repositories, and data interchange standards. It supports technology solutions that enable semantic (meaning-based) interoperability within the biomedical/clinical research arena and between research and the healthcare arena. The clinical research semantics are represented as a set of visual diagrams which describe information relationships, definitions, explanations, and examples used in protocol-driven biomedical research. These diagrams are expressed using the iconography and grammar of the Unified Modelling Language (UML), the HL7 Reference Information Model (RIM), and a Web Ontology Language (OWL).

ISO 14199:2015 establishes the links between protocol-driven research and its associated regulatory artefacts including the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance along with all associated regulatory artefacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.

Informations générales

  •  : Publiée
     : 2015-09
    : Norme internationale à réviser [90.92]
  •  : 1
  • ISO/TC 215
    35.240.80 
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