- Developed by CDISC, HL7, ISO, NCI, and the FDA.
- The goal is to produce a shared view of the dynamic and status semantics for the domain of basic, pre-clinical, clinical, and translational research and its associated regulatory artifacts.
- Enable semantic interoperability.
- Expressed as a collection of visual diagrams using the Unified Modeling Language (UML).
- The set of visual diagrams, their relationships, definitions, explanations, and examples are collectively referred to as the BRIDG model.
- Can be used as a reference model, a data integration/mapping solution, an exchange format, an ontology, and to create a BRIDG-base database.
- Reference Model - Source for clinical research data semantics and/or a foundation model to develop a consistent set of concepts representing the domain of translational research
- Facilitate semantic agreement between different stakeholders
- Validate requirements for a system
- Integration/Mapping Solution - Hub and spoke model - different standards are the spokes and are mapped to a single point (BRIDG, the hub)
- Different standards can be translated into any of the other spokes without having to do many different point to point mappings
- Exchange Format - Subsets of BRIDG classes representing related concepts can be exchanged in XSD/XML format
- Physical Database - Can be used to create logical and physical database models in support of clinical research software solutions
- Ontology - Many of BRIDG’s definitions have been converted into an OWL representation, bringing to light issues that have been addressed to make the UML model more consistent
- The BRIDG Model has been used in a variety of ways by different organizations.
- The BRIDG team mapped data elements in OMOP, PCORNet, 12B2ACT, and Sentinel to BRIDG and the cancer Data Standards Registry and Repository (caDSR) team registered the common data elements (CDEs) reusing the BRIDG components.
- Common Data Model Harmonization (CDMH) project. The goal is to map the above standards to BRIDG and then map them to FHIR profiles and resources.
- CDEs within caDSR for high-profile CIBMTR forms have been extracted and associated to the BRIDG model.
- Thomas Jefferson University designed and implemented a cancer research information system based on the BRIDG model.
- FDA’s Janus’s conceptual model is informed by the BRIDG model.
- PAREXEL utilized BRIDG as the basis for a central common data model to increase semantic consistency and quality across a diverse portfolio of produce and services.
High Level Concepts
BRIDG, HL7, and FHIR
- BRIDG is a project under the Biomedical Research and Regulation Work Group (BR&R)
- BRIDG serves as its domain information model and is intended to provide the semantic foundation to the artifacts developed by the WG.
- FHIR Resources owned by BR&R and updated to better align with BRIDG:
- List of key usage scenarios supported by BRIDG:
- Submission of study data to a central repository or research repository
- Clinical trial participant registration and submission of the registration data to ClinicalTrials.gov and other registries
- Submit subject lab data to CRO and/or sponsor
- Study setup, management, and site network management
- Sharing protocol and CRF metadata and subject data among trial stakeholders
- Adverse event reporting
- The model has over 300 classes. As a result, the BRIDG team has created smaller diagrams, which are subsets of the BRIDG model.
- There are Topic-Based Groupings – focused on small sets of related classes, attributes, and associations.
BRIDG / mCODE Comparison
- mCODE is only focused on oncology. BRIDG has many domains
- BRIDG is expressed as a collection of visual diagrams using the Unified Modeling Language (UML). mCODE is expressed using FHIR profiles.
- High level concept comparison:
- Study information (site, protocol, arm, etc.) are in BRIDG, but not mCODE.
- Some details of organization (distributor, manufacturer, etc.) are in BRIDG, but not mCODE.
- Some product details are in BRIDG (material, container, etc.), but not mCODE.
- Some observations are in BRIDG (imaging, adverse event, etc.), but not mCODE.
- Comparison of BRIDG oncology attributes vs. mCODE attributes is attached.