Reference number
ISO 14199:2015
International Standard
ISO 14199:2015
Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
Edition 1
2015-09
Preview
ISO 14199:2015
66767
No disponible en español
Publicado (Edición 1, 2015)
Esta publicación se revisó y confirmó por última vez en 2021. Por lo tanto, esta versión es la actual.

ISO 14199:2015

ISO 14199:2015
66767
Idioma
Formato
CHF 63
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Resumen

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.

Informaciones generales

  •  : Publicado
     : 2015-09
    : Norma Internacional para revisar [90.92]
  •  : 1
     : 8
  • ISO/TC 215
    35.240.80 
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