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BRIDG 4.0 HTML.zip

By Wendy Nan Ver Hoef1, Smita Hastak1, Lloyd Mckenzie2, Julie Evans3, Boris Brodsky4

1. Samvit Solutions, Contractor, National Cancer Institute, HL7 2. Gevity, Contractor National Cancer Institute, HL7 3. CDISC 4. FDA, HL7

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Abstract

Download this file to save and install a local copy of the HLTML version of BRIDG 4.0.

The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort engaging stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 BRIDG 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 view of the dynamic and static semantics for the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts. This domain of interest is further defined as:

  • 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, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.

Cite this work

Researchers should cite this work as follows:

  • Wendy Nan Ver Hoef; Smita Hastak; Lloyd Mckenzie; Julie Evans; Boris Brodsky (2015), "BRIDG 4.0 HTML.zip," https://ncihub.cancer.gov/resources/1583.

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Tags

  1. BRIDG
  2. HTML
  3. models
  4. UML