M00001433
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ISO 14199 1st Edition, September 15, 2015 Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model
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Availability date: 07/13/2021
Description / Abstract:
This International Standard 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).
This International Standard 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.