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The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort engaging stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM) Work Group, the US National Cancer Institute (NCI), and the US Food and Drug Administration (FDA). The goal of the BRIDG Model is to produce a shared produce a shared view of the dynamic and dynamic and static semantics for the domain of protocol-driven research and its associated domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. This domain domain of interest is further defined defined as:Protocol-driven research and its associated regulatory artifacts: i.e. the data

The data, organization, resources, rules,

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and processes

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involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a

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drug, procedure, process, subject characteristic, biologic, cosmetic, food or

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device on a human, animal, or other subject or substance plus all

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associated regulatory artifacts

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required for or

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derived from this effort,

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including data specifically associated with post-marketing

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adverse event reporting.

For additional information on the BRIDG Model, please go to the BRIDG Model website.

Related Projects

Life Sciences Domain Analysis Model (LS DAM)

Biomedical Research Business Architecture Model