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BRIDG Overview

BRIDG Overview. Clinical Observation Interoperability March 18, 2008. BRIDG Background. Stakeholders: HL7, CDISC, NCI/caBIG, FDA Goals: shared semantics Domain of Interest: protocol driven research Project Organization: BAB, THC. BRIDG Content.

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BRIDG Overview

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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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