Model Subset Diagrams & Reports The BRIDG model has over 300 classes and it becomes challenging to comprehend the entire model in one diagram. Therefore the BRIDG modeling team has created smaller diagrams which are subsets of the BRIDG model to make it more digestible and user-friendly. Note that some classes show up in more than one diagram. Users are encouraged to browse the different kinds of diagrams and reports to find the ones that best fit their requirements. With each release, it is possible that more diagrams will be created. Each diagram includes a link to download an associated diagram report. Clinical Research Data Exchange Groupings The BRIDG model supports a majority of the semantics of clinical research. Here are some representative data exchange scenarios supported by BRIDG. These diagrams are based on requirements that were brought to the BRIDG project for harmonization. Since CDISC is an established data exchange standard for clinical research, a subgroup of diagrams relevant to CDISC is highlighted. Developing a Protocol with Computable Representation of Study Design: Structured Protocol - Backbone Structured Protocol - Core Protocol Concepts Structured Protocol - Schedule of Activities Structured Protocol - Relationships to Support Complex Activities Structured Protocol - Operational Mode Obtaining IRB Approval for a Study Registering a Trial at ClinicalTrials.gov Managing Study and Site Setup Evaluating Subject Eligibility Registering a Study Subject on a Trial Establishing Subject’s Study Calendar Capturing Medical History Administering a Study Drug Performing a Surgical Procedure Performing a Lab Test Processing a Specimen Interfacing with a DICOM-Based Imaging System (diagram under construction) Identifying Medical Conditions Evaluating Disease Progression Reporting an Adverse Event (via Medwatch?) (diagram under construction) Discovering a Product Problem Documenting Study Milestones Identifying Protocol Deviations Processing Protocol Amendments Submitting Study Data to Sponsor/Central Repos? (diagram under construction) Submitting Study Data to Regulator (diagram under construction) Conducting Post-Market Surveillance (diagram under construction) CDISC Diagrams CDISC Lab Data Model v1.0.1 SDTM IG v3.2 SDTM IG v3.1.3 SDTM Exposure (EX) Domain SDTM Disease Response (RS) Domain SDTM Vital Signs (VS) Domain Project-Based Groupings The scope of the diagrams in this section corresponds with the semantics of several projects that have been harmonized with BRIDG. These project-based diagrams allow the project teams to focus on just their semantics as represent in the BRIDG model Many of diagrams showing only the classes, attributes and associations to which a given project’s concepts map, hiding all classes, attributes and associations not used in that project’s mappings. Anatomic Pathology Structured Report (APSR) Common Data Model Harmonization (CDMH) National Biomedical Imaging Archive (NBIA) National Marrow Donor Program (NMDP) Surveillance, Epidemiology & End Results (SEER) Topic-Based Groupings The diagrams in this section focus the user’s attention on small sets of related classes, attributes and associations. Activities Adverse Events Animal BiologicEntity and Related Classes Diagnosis Documents and Document Versions Lab-Related Classes Observations and Results Oncology Oncology & Imaging Organization Organization-Related Classes - no attributes Participant Registration Performer Person Roles Product Registering a Trial at ClinicalTrials.gov Specimen Containers & Storage Equipment StudySite and StudySubject Subject and ExperimentalUnit Comparison Comprehensive Model Spreadsheet The BRIDG model is made up of over 300 classes and to make it easier to search, all class and attribute definitions have been exported to a single spreadsheet. This shows all classes and attributes from the latest official release of BRIDG. Download the Comprehensive Model Spreadsheet by clicking here.