1. Clinical Observation Interoperability March 18, 2008
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 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. 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)
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.

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 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

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