BRIDG

The Biomedical Research Integrated Domain Group (BRIDG) Model is a collaborative effort engaging stakeholders from the Clinical Data Interchange Standards Consortium (CDISC), the HL7 Regulated Clinical Research Information Management Technical Committee (RCRIM TC), the National Cancer Institute (NCI) and its Cancer Biomedical Informatics Grid (caBIG®), and the US Food and Drug Administration (FDA). The BRIDG model is an instance of a Domain Analysis Model (DAM). The goal of the BRIDG Model is to produce a shared view of the dynamic and static semantics for the domain of protocol-driven research and its associated regulatory artifacts. This domain of interest is further defined as:

Protocol-driven research and its associated regulatory artifacts: i.e. 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.

Project Site

BRIDG GForge Project Page: BRIDG - Project Page

BRIDG GForge File Release Site: BRIDG - File Release Site

Release 3.0.3

The changes represented in Release 3.0.3 are due to the harmonization of:

• HL7 Integrated Case Safety Report (ICSR) Release 2
• CDISC Study Data Tabulation Model (SDTM) Implementation Guide v3.1.2
• CDISC Clinical Data Acquisition Standard Harmonization (CDASH) v1.1
• ISO Joint Initiative Council (JIC) ballot

The main concepts that were affected by the harmonization of the ICSR model are new product attributes and relationship. The main concepts that were affected by the harmonization of the CDISC models are new structures to support the context needed for questionnaires (e.g., “has as focal context” and “is recorded as a result of” relationships) and the use of uncertain date ranges for references to “relative” dates.

As with the previous version of BRIDG, this release has multiple perspectives to address the needs of all anticipated users of the BRIDG model.

Release 3.0.2

The majority of the changes represented in Release 3.0.2 are due to the harmonization of four National Cancer Institute (NCI) projects: caBIG Central Cancer Patient Registry (C3PR), Patient Study Calendar (PSC), Cancer Adverse Event Reporting System (caAERS) and LabViewer. The central concept that has affected the model is versioning of documents and studies. In addition, a small number of changes were made to address comments from the ISO Joint Initiative Council (JIC) ballot.

Release 3.0.1

The scope of release 3.0.1 is limited to two main areas:

• A few model changes and quite a few new mapping tags due to the harmonization of HL7 Regulated Clinical Research Information Management’s (RCRIM) Clinical Trial Registration and Results (CTR&R) project;
• Changes due to the resolution of comments from the 2009 CDISC BRIDG review.

As with the previous version of BRIDG, this release has a layered approach to address the needs of both domain experts and HL7-savvy experts.

Release 3.0

BRIDG 3.0 is a restructuring of the semantics already in the BRIDG 2.2 model. The restructuring was done because domain experts found the earlier versions of the model increasingly harder to understand and because technical experts found it difficult to unambiguously map the BRIDG concepts to the HL7 Reference Information Model (RIM). To resolve those problems, BRIDG Release 3.0 introduces three layers:

• A sub-domain specific layer, allowing domain experts to see their semantics in the 5 user-friendly sub-domain models: Protocol Representation, Study Conduct, Adverse Event, Regulatory, Common;
• A comprehensive layer that combines all the sub-domains in a single view of the harmonized and shared semantics;
• A RIM-based layer that represents the BRIDG concepts but uses the RIM classes and HL7 diagrammatic representation for the HL7-savvy technical personnel.

BRIDG 3.0 also includes tags on model elements identifying the source model element(s) from which they were derived, a revision to the Study Design portion of the model to make it more flexible, the adoption of a UML style guide, and an updated User's Guide.

Release 2.2

With release 2.2, BRIDG contains new semantics to support two of the FDA's CDISC HL7 messages. BRIDG 2.2 also contains changes to support the use of an ontology tool for model maintenance.

• FDA's CDISC HL7 Study Participation Message
• Portions of the FDA's CDISC HL7 Study Design Message, i.e. the semantics not contained in the Common Message Element Types (CMETs) referenced by that message.
• Definitions for all associations
• Indication of root and leaf classes

Further changes in support of the ontology tool can be expected for BRIDG 3.0 (under construction), along with a new three layer approach to make the model more easily understood by different stakeholders such as domain and technical experts.

Release 2.1

The scope of BRIDG 2.1 is to strengthen the representation of the core aspects of a protocol itself and the people, organizations and the roles played in the context of a study.

• Clinical Trial Registries – includes both the World Health Organization (WHO) and clinicaltrials.gov registries
• Protocol Abstraction
• Eligibility Criteria (draft)

In addition to the new semantics, BRIDG Release 2.1 also uses HL7 V3 R1 data types instead of ISO data types. This will position the model to evolve to RIM compliance in BRIDG Release 3.0.

Release 2.0

The scope of BRIDG release 2.0 covers the Adverse Event (AE) project and the Participant Registry project. It also has initial structures for Person and Organizational relationships. The AE project and modeling effort was a coordinated effort involving projects from FDA, HL7, NIH and NCI. The project artifacts from all the projects have been formally harmonized with the BRIDG model over the last few months.

The specific projects and their sponsoring organizations are as follows:

• Adverse Event Model (ICSR from FDA and HL7; FAET from NIH; SDTM from CDISC; AdEERS and caAERS from NCI)
• Participant Registry Project (NCI)
• Person/Organization - Draft (NCI)

Release 1.1

The scope of BRIDG release 1.1 covers 2 projects from CDISC. The project artifacts from both these efforts have been formally harmonized with the BRIDG model over the last 3 months.

The specific projects and their sponsoring organizations are as follows:

• Study Data Tabulation Model Implementation Guide v 3.1.1 -- SDTM (CDISC)
• Trial Design Model –TDM (CDISC)

Release 1.0

The scope of BRIDG release 1.0 covers 5 projects from the various stakeholders. The static models (UML Class Diagrams) from these five projects have been formally harmonized with the BRIDG model over the last year. The specific projects and their sponsoring organizations are as follows:

• Study Data Tabulation Model -- SDTM (CDISC) – 50%
  
• caXchange/LabHub(including Clinical Trial Periodic Update and Lab Model) (NCI/HL7 RCRIM TC/CDISC)
  
• Regulated Product Submission -- RPS (HL7 RCRIM TC/FDA)
  
• Cancer Clinical Trials Object Model -- CTOM (NCI)– 50%
  
• Patient Study Calendar -- PSC, Phase 1 (NCI)

User Information

Subscribe to the BRIDG Users Listserv

Download BRIDG FAQ (PDF - 128KB)

Presentations relating to BRIDG

BRIDG Harmonization Package

Based on input from the BRIDG user community and other stakeholders, the BRIDG SCC has taken a first cut at formalizing the BRIDG model harmonization process. We have built several documents in support of this process, which can be downloaded below as a zip file -- BRIDG Harmonization Package. This zip file contains the following documents:

• The Process for Harmonizing Project Models with BRIDG.PDF
• BRIDG_Model_Harmonization_Request_Form.doc
• Principles for Determining What is in BRIDGs Scope and What is Not.PDF
• BRIDG Mapping Spreadsheet Template.xls
• BRIDG Modeling and Naming Conventions.PDF
• How to Build a BRIDG-Based Analysis Model.PDF
• README for BRIDG Harmonization Package.PDF

Note: The BRIDG harmonization process document that was available from this site has been updated and is now part of this package.

Download the BRIDG Harmonization Package

Acknowledgments

BRIDG is a unique collaborative effort between the following groups:

• CDISC Board of Directors and Teams
• HL7 RCRIM Technical Committee
• NCI caBIG® program
• US Food and Drug Administration

The efforts of the following key individuals were essential to the success of BRIDG:

Landen Bain (CDISC)
Ken Buetow, Ph.D. (NCI)
Julie Evans (CDISC)
Doug Fridsma, M.D., Ph.D (University of Pittsburgh)
Smita Hastak (ScenPro, Inc.)
Becky Kush, Ph.D. (CDISC)
Charlie Mead, M.D., M.S. (Booz Allen Hamilton, Inc./NCI)

Semantic Coordination Committee (SCC) Members

BRIDG Board of Directors

Contact Information

For all enquiries please contact: bridgTHC-L@list.nih.gov