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HL7 Working Group MeetingOrlando, Florida14 January 2009
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BRIDG 2.1 released October 2008• New semantics in 2.1 are Clinical Trial Registry, Protocol Abstraction, minimal Eligibility
Criteria (draft)
Current work for next release (R2.2): include semantics of HL7 CDISC Study Design and Study Participation messages in BRIDG
• Study Design – R2.2• Study Participation – R2.2• ICSR - R2.x• Subject Data - R2.x• Common Product Model – out of scope for BRIDG
Release 3 schedule will be determined by start of Q2 of 2009
New THC Member – Marti Velezis
New Board Member – Jack Jones
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Project Stakeholder
Study Data Tabulation Model (SDTM) CDISC
Regulated Product Submission (RPS) FDA/HL7 RCRIM
Patient Study Calendar (PSC) NCI
Trial Design Model (TDM) CDISC
caXchange/LabHub NCI/HL7 RCRIM TC/CDISC
Clinical Trial Object Model (CTOM) NCI
Adverse Events CDISC, NCI, FDA, Federal AE Task Force
Cancer Central Clinical Patient Registry (C3PR)
NCI
Person / Organization (Player / Scoper) NCI
Clinical Trial Registry CDISC
Protocol Abstraction NCI
Eligibility Criteria (draft) NCI, CDISC
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Name Affiliation
Charlie Mead NCI / Booz Allen HamiltonSteve Sandberg NCI / MayoSmita Hastak NCI / ScenproWendy Ver Hoef NCI / ScenproBecky Angeles NCI / ScenproJulie Evans CDISCSaurin Mehta CDISC / NovartisJay Levine FDAMarti Velezis CDISC / ii4SM
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Appointed Members
Charlie Mead NCIArmando Oliva FDADave Iberson-Hurst CDISCChuck Jaffe HL7
At Large Members Term (Yrs)
Christopher Chute 2Becky Kush 3John Speakman 2Jack Jones 3
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For projects that want to harmonize semantics with BRIDG: Project team should contact THC via website listserv for BRIDG THC at (get
listserv name from Smita) The THC will assign a point of contact for the project. The THC point of
contact will answer BRIDG questions, consult with team about progress, schedule BRIDG harmonization, bring project issues to the THC, etc.
Project team representatives will attend the harmonization meeting with the THC
For general questions about BRIDG Post to the BRIDG listserv
THC members are responsible for communicating important BRIDG info to the stakeholders
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Currently, BRIDG does not include disease-specific semantics
Current proposed strategy (with no definitive answer yet) Disease specific content will be subclasses of BRIDG classes. Disease specific models will be managed by the disease domain
experts. We need to consider the line between information models and
terminology models We need R3.0 (2 layer model) to actively address strategy.
The lower layer of R3.0 will be the RCRIM DMIM -> mapping to RMIMs will be possible, e.g., Clinical Statement RMIM
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Protocol Representation V1.0 in BRIDG 2.1 Documentation in progress
• PRG review Feb, 2009• Final due Mar 31, 2009
Post for 30 day comment period Review, respond and revise per comments Update Protocol Representation in BRIDG 3.0 BRIDG 3.0 JIC ballot – expected Q3/Q4 2009 balloted Protocol Representation model
Clinical Trial Tracking, Study Summary (SDTM)
Clinical Trial Registry
CDISC Trial Design Part I(arms, elements, visits)
CDISC Trial Design Part IIPlanned assessments
& interventions (NCI Study Calendar)
Eligibility Criteria(most common)
CDISC Statistical Analysis Plan
Other Protocol Template Sections and Attachments
Protocol RepresentationExcel Spreadsheet
BRIDG Mapping; Harmonization
PR V 1.0 StandardDocumentation
XML Schema Development
(ODM Extension)
PR V 1.x(2009)
PR V 1.02008
CDISC-HL7 Protocol Representation Standard - Development
