1. BRIDG Overview Clinical Observation Interoperability March 18, 2008

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

3. 3 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

4. 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. 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. 6 Backbone – Part 1 Entity Role Participation

7. 7 Backbone – Part 2 Document Activity Result

8. 8 BRIDG – Close Up Labs Vitals Meds

9. 9 SDTM Implementation Guide

10. 10 SDTM Mapping

11. 11 HL7 RIM

12. 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. 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. 14 Questions http://bridgmodel.org