BRIDG

The BRIDG Model is a collaborative effort of 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 the US Food and Drug Administration (FDA) to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest, i.e. the domain of clincial and pre-clinical protocol-driven research and its associated regulatory artifacts.

The BRIDG model is an instance of a Domain Analysis Model (DAM). As such, it depicts a shared representation of the dynamic and static semantics of a particular domain-of-interest. In the case of the BRIDG model, the domain is 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 biologic subject or substance plus all associated regulatory artifacts required for or derived from this effort.

Project Site

BRIDG GForge Project Page	BRIDG - Project Page
BRIDG GForge File Release Site	BRIDG - File Release Site

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 Calender -- PSC, Phase 1 (NCI)

User Information

Subscribe to the BRIDG Users Listserv

Download BRIDG FAQ (PDF - 128KB)

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)

Technical Harmonization Committee (THC) Members

BRIDG Board of Directors

Contact Information

For all enquiries please contact: bridg@mail.nih.gov