Clinical Observation Interoperability March 18, 2008

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Presentation transcript:

Clinical Observation Interoperability March 18, 2008 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 CDISC SDTM – 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

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

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) the BRIDG Model can be “implementation independent” in the sense that it should not specify structures like primary or foreign database keys, but it cannot remain implementation independent in the sense of ignoring run-time terminology bindings.

Backbone – Part 1 Entity Role Participation

Backbone – Part 2 Document Activity Result

BRIDG – Close Up Labs Meds Vitals

SDTM Implementation Guide

SDTM Mapping

HL7 RIM

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

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

Questions http://bridgmodel.org