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
Obtaining IRB Approval for a Study
Registering a Trial at ClinicalTrials.gov
Evaluating Subject Eligibility
Registering a Study Subject on a Trial
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)
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
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.
Topic-Based Groupings
The diagrams in this section focus the user’s attention on small sets of related classes, attributes and
associations.
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.