The BRIDG Model is a domain analysis model representing the realm of protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by clinical research domain experts and would provide a semantic basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare.
Protocol-driven research and its associated regulatory artifacts are 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, 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.
BRIDG is also the underlying reference model for the CDISC SHARE Metadata Repository.
CDISC has solicited comments on Release 4.0 of the BRIDG model. BRIDG is an information model supported by multiple stakeholders, which is used by CDISC as a reference model to guide standards development, improve consistency among standards, and help support interoperability. The BRIDG Model 4.0 package includes mappings of SDTMIG 3.1.3 and CDASHv1.1 to BRIDG. It also includes a mapping of the draft SDTMIG for Pharmacogenomics/Genetics to BRIDG. The public comment period for BRIDG R4 closed on May 11, 2015, and comments are now being reviewed and addressed. More information on BRIDG R4 can be found at http://bridgmodel.org/.
Current Production Version: BRIDG Release 3.2
The Clinical Data Interchange Standards Consortium (CDISC), Health Level Seven (HL7), the U.S. Food and Drug Administration (FDA) and the U.S. National Cancer Institute (NCI) are pleased to announce the release of version 3.2 of the BRIDG) model of the semantics of protocol-driven clinical research. Release 3.2 of the model is available for download at: http://bridgmodel.nci.nih.gov/download_model.
Description of the changes in the BRIDG R3.2
The BRIDG Domain Analysis Model project was initiated by CDISC in 2003 to support harmonization among the CDISC standards and between CDISC and HL7. Shortly thereafter, the US National Cancer Institute (NCI), HL7's Regulated Clinical Research Information Management (RCRIM), and the US Food and Drug Administration (FDA) joined with CDISC to collaborate on the development and maintenance of the model. For more details about the BRIDG Model's history, see http://bridgmodel.nci.nih.gov/about_bridg/background.