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Overview of BRIDG Framework in Clinical Research Data Interoperability

The BRIDG (Biomedical Research Integrated Domain Group) Framework aims to facilitate interoperability in clinical research by standardizing data models and semantics across stakeholders such as HL7, CDISC, and NCI. It encompasses various components including the Clinical Document Architecture (CDA), Submission Data Tabulation Model (SDTM), and Cancer Trial Object Model (CTOM), among others. The project emphasizes shared semantics, promoting efficient protocol-driven research. Additionally, the framework incorporates Unified Modeling Language (UML) for both static and dynamic modeling, ensuring implementation independence and contextual relevance.

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Overview of BRIDG Framework in Clinical Research Data Interoperability

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  1. BRIDG Overview Clinical Observation Interoperability March 18, 2008

  2. BRIDG Background • Stakeholders: HL7, CDISC, NCI/caBIG, FDA • Goals: shared semantics • Domain of Interest: protocol driven research • Project Organization: BAB, THC

  3. BRIDG Content • CDISCSDTM – Submission Data Tabulation Model • HL7 CDA – Clinical Document Architecture • NCI/HL7/CDISC caXChange/LabHub • HL7 RPS – Regulated Product Submission • CDISC TDM – Trial Design Model • NCI PSC – Patient Study Calendar • NCI CTOM – Cancer Trial Object Model • NCI/? AE – Adverse Events • NCI C3PR – Cancer Central Clinical Participant Registry

  4. BRIDG Components • UML (Unified Modeling Language) • Static Model: Class diagram, Object diagram • Dynamic Models: Activity diagrams, State diagrams, Sequence diagrams • Abstract Data Types (HL7) • Binding to Terminologies (NCI) • Mapping to application models • Mapping to HL7 RIM

  5. Binding to Terminologies • specifies the shared semantics at a comprehensive level • at attribute level • to both local and global terminologies • occurs in context of run-time instances • must remain implementation independent • caBIG™ Cancer Data Standards Repository (caDSR) • Enterprise Vocabulary Service (EVS)

  6. Backbone – Part 1 • Entity • Role • Participation

  7. Backbone – Part 2 • Document • Activity • Result

  8. BRIDG – Close Up Labs Meds Vitals

  9. SDTM Implementation Guide

  10. SDTM Mapping

  11. HL7 RIM

  12. HL7 Mapping • BRIDG attributes may map to • Class • Attribute • Data Type • Vocabulary (for structural codes, e.g., participation type) • May require several iterations • Changes to RIM • Changes to BRIDG

  13. Eligibility Criteria • ASPIRE – Agreement on Standardized Protocol Inclusion Requirements for Eligibility, Joyce Niland, City of Hope • HL7 CRFQ – Clinical Research Filtered Query, Charlie Mead, BAH

  14. Questions • http://bridgmodel.org

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