BRIDG Update

BRIDG Update

May HL7 Working Group Meeting5 May 2008

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BRIDG Update

• BRIDG Board of Director News• BRIDG Technical Harmonization Committee

News• BRIDG Release 2.0 Status

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What is BRIDG?Biomedical Research Integrated Domain Group

• A formal model

• A communication bridge

• An open community of stakeholders

• The semantic foundation for application and message development

BRIDG ScopeProtocol-driven research and its associated regulatory

artifacts,

i.e. the data, organization, resources, rules, and processes involved in the formal assessment of the

utility, impact, or other pharmacological, physiological, or psychological effects of a drug,

procedure, process, or device on a human, animal, or other biologic subject or substance plus all associated regulatory artifacts required for or derived from this

effort.

BRIDG Board of Director News

• New Name: BRIDG Board of Directors• Dr. Christopher Chute elected as Chair – 1 year

term• New charter developed which includes by-laws and

operating procedures– 2 types of members: • Each founding stakeholder appoints 1 member• Remaining 3-7 at large members elected to 3 year staggered

term

– Will elect one at large member this year

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BRIDG Board of Directors

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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 2Christo Andonyadis 1

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BRIDG THC

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 FDA

Release 2.0 Plan – 1• Release 2.0 scheduled for April 2008

– Update: Changed to May 2008

• R2.0 new content: AE, C3PR (NCI’s Patient Registry)

• Full binding of all static attributes to HL7 V3 data types – – Clarification: Will bind to HL7 V3 R2.

• Candidate terminology lists/value sets (drawn from existing standards if possible) for all attributes bound to ‘coded concept descriptor’ data types– Update: Develop full description of meta-data/data/ value-set binding to

outline THC responsibilities going forward

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Release 2.0 Plan - 2• Consolidation of ‘business process pillars’ in the model with guideline of

<<not>> creating the RIM problem of ‘duplicitous attributes.’

• Introduction of formal business rules as class invariants using both free text and equivalent parsable OCL statements

• Representation of ‘player/scoper’ semantics

• Complete mapping of BRIDG Model static attributes to the HL7 RIM

• Test evaluation of strategy for incorporating BRIDG Model ‘sub-domains’ (e.g. cancer-specific semantics, TB semantics) using NCI’s CTOM

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Release 2.0 Plan – 3• Creation of more exemplary instance diagrams (e.g. AE content, SDTM

IG, etc.)

• New: Resolve several naming and core representational issues around TDM, study calendar, etc

• Resolution of several model inconsistencies (e.g. Observation – ObservationResult vs Assessment (no AssessmentResult)

• Infrastructure improvements including CVS, FAQ, and revised mapping documents– Scoped for R2: FAQ + Mapping Document position. Infrastructure still in planning

stage

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R2 Policy Changes

• 1-2 releases per year, at the discretion of the THC

• Project mapping spreadsheets will be owned and maintained by project teams rather then the BRIDG THC. So, these spreadsheets will no longer be published with each release. BRIDG THC will publish the first mapping from BRIDG to RIM.

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What’s In Release 2.0?

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

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What’s Coming After Release 2.0?Project Harmonization Date Stakeholder Clinical Trial Registry June 2008 CDISC / HL7

Protocol Abstraction – goes with CTR June 2008 NCI

Protocol Representation CDISC / HL7

Structured Product Label FDA

Cardiology Duke Clinical Research

Tuberculosis Duke Clinical Research

Statistical Analysis, including SAP Late 2008 / early 2009 CDISC

RPS Release 2 End of 2008? FDA

CDISC HL7 Message Project Gaps Late 2008 / Early 2009? FDA

Pharmacogenomics FDA/CDISC/HL7

Eligibility Criteria (EMR perspective) W3C Clinical Observation Interoperability

Questions and Answers

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