BRIDG Overview

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

• 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)

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