BRIDG is a domain analysis model that represents the realm of protocol-driven clinical, pre-clinical, translational and basic research. This breadth includes concepts from Common (i.e., concepts shared by all research protocols), Protocol Representation, Study Conduct, Adverse Events, Biospecimen, Molecular Biology, Experiment, Statistical Analysis and Regulatory subdomains. These research concepts provide a shared understanding of biomedical semantics (i.e., what each concept means and how it relates to other concepts) so that these semantics can be easily understood by subject matter experts in the biomedical domain.
Software architects or developers and data managers can use the model to design software systems and databases, respectively, that share the same semantics. This use of BRIDG helps support the meaningful exchange of data between those systems; this approach has been taken by academic, biopharmaceutical, government and regulatory organizations as well as clinical research organizations worldwide. The biomedical semantics of BRIDG are described 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.”
BRIDG uses healthcare datatypes as its syntax to frame these semantics in a way that “bridges” CDISC Foundational Standards, research and healthcare concepts, and many organizations. Semantic and syntactic standards are necessary to facilitate software interoperability, where different systems can meaningfully exchange data. When used to design software systems and databases, BRIDG supports interoperability.
BRIDG is a CDISC, HL7 (Healthcare Level 7) and ISO (International Standards Organization) standard. BRIDG 4.1.1 and prior releases are available to view or download, requiring Enterprise Architect tool, at the model’s website.
Stakeholders and Development
For nearly ten years, CDISC, U.S. National Cancer Institute (NCI), Food and Drug Administration (FDA), HL7 and ISO have been key BRIDG stakeholders. These stakeholders, as well as members of academia, clinical research organizations, information technology teams and others have participated in the ongoing development and maintenance of BRIDG through its Modeling Team, Working Group and Steering Committee.
BRIDG Relationships to Other CDISC Standards
Because BRIDG includes concepts spanning the full spectrum of biomedical and health research, it can be used as a reference tool when creating new standards or adding new content to an existing standard. This referencing ensures the relationships between, and among concepts, in a new or expanding standard, are compliant with an existing model that has been vetted by subject matter experts. BRIDG is often used as a reference tool when developing Foundational Standards, Therapeutic Areas and Biomedical Concepts. Mappings from these standards to BRIDG can be explicitly defined. These bindings, plus several versions of BRIDG, have been imported in the CDISC SHARE metadata repository to make them available electronically.
In addition to reference, many CDISC Foundational Standards are harmonized within BRIDG. The model include mappings to Study Data Tabulation Model Implementation Guide (SDTMIG) and CDASH. The Pharmacogenomics/Genetics Implementation Guide is also harmonized with BRIDG to inform its representation of genomic, proteomic and other related semantics from humans and microorganisms. These mappings to the BRIDG model provide a visual representation of CDISC standards, and help ensure different software systems and databases developed using the model share semantics to meaningfully exchange data. For more details on BRIDG's release history, please visit http://bridgmodel.nci.nih.gov/about_bridg/background.
Recent BRIDG Releases
BRIDG is an actively developed model, where modeling activities are largely performed as part of an HL7 sponsored BRIDG Work Group and guidance and prioritization from a Steering Committee, consisting of representatives from key stakeholders and academia. The download or view releases of BRIDG, navigate to http://bridgmodel.nci.nih.gov/download_model/bridg-releases/.