Draft International Standard
ISO/DIS 14199
Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
Reference number
ISO/DIS 14199
Версия 2
Draft
International Standard
Предпросмотр
u
ISO/DIS 14199
83433
недоступно на русском языке
Проект данного международного стандарта находится на этапе рассмотрения членами ИСО.
Текущее издание: ISO 14199:2015

ISO/DIS 14199

ISO/DIS 14199
83433
Формат
Язык
CHF 63
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Тезис

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.

Общая информация

  •  : В стадии разработки
    : Рассылка краткого отчета по итогам голосования [40.60]
  •  : 2
  • ISO/TC 215
    35.240.80 
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