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BRIDG UpdateHL7 Working Group Meeting
Lake Buena Vista, FL17 May, 2011
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Agenda
• BRIDG Overview• Recent Accomplishments• Current Efforts• Next Steps
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BRIDG Overview• BRIDG Purpose:
A collaborative effort to produce a shared view of the dynamic and static semantics that collectively define a shared domain-of-interest.
• Domain-of-interest/scope:Protocol-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, subject characteristic, biologic, cosmetic, food or device on a human, animal, or other subject or substance plus all associated regulatory artifacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.
• Stakeholders:• Process:
Board of Directors prioritizes projects and semantic coordination committee consults with projects and harmonizes project models into main model with help of project analysts/SMEs
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Recent Accomplishments
• Released BRIDG 3.0.3 December, 2010• Balloted BRIDG as ISO JIC Standard in May,
2010 – BRIDG passed both HL7 and ISO ballots– Currently in the next round of balloting,
responding to suggested changes from ISO HQ
• Started a BRIDG SMEs group– Experts who help SCC vet new/modified semantics
BRIDG Release 3.0.3 Changes
• HL7 Integrated Case Safety Report (ICSR) Release 2
• CDISC Study Data Tabulation Model (SDTM) Implementation Guide v3.1.2
• CDISC Clinical Data Acquisition Standard Harmonization (CDASH) v1.1
• ISO Joint Initiative Council (JIC) ballot – remainder of ballot changes/issues resolved
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Release Projects Harmonized with BRIDG as of Dec., 2010 Stakeholder
R1.0: Jun., ‘07 Regulated Product Submission (RPS) FDA/HL7 RCRIM
Patient Study Calendar (PSC) NCI
Clinical Trial Object Model (CTOM) NCI
caXchange/LabHub NCI/HL7 RCRIM TC/CDISC
R1.1: Oct., ‘07 Study Data Tabulation Model (SDTM) CDISC
Trial Design Model CDISC
R2.0: Jun., ‘08 Adverse Events CDISC, NCI, NIH, US Federal Gov’t, FDA
Player / Scoper for Person and Org NCI, CDISC
Patient Registry (C3PR) NCI
R2.1: Oct., ‘08 Clinical Trial Registry (COPPA, ct.gov, WHO, PRV1.0) CDISC, NCI
Protocol Abstraction (COPPA – Correlations, Organizations, People and Protocol Abstraction)
NCI
R2.2: May, ‘09 CDISC HL7 Message Study Design (partial) FDA
CDISC HL7 Message Study Participation FDA
R3.0: Oct., ‘09 (Architecture Redesign only)
R3.0.1: Feb., ‘10 Clinical Trials Registration & Results, CDISC Ballot Cmts HL7 RCRIM, CDISC
R3.0.2: Aug., ’10 Central Clinical Participant Registry (C3PR) NCI
caBIG Adverse Event Reporting System (caAERS) NCI
LabViewer (LV) NCI
Patient Study Calendar (PSC) NCI
ISO Ballot Comment Responses (part 1) CDISC
R3.0.3: Dec., ‘10 SDTM 3.1.2, CDASH, TDM, CDISC, DAM, ISO JIC Ballot Comments CDISC
HL7 ICSR Message FDA, HL7
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Current Efforts• Re-harmonization of HL7 Study Design Message• Harmonization of CDISC Operational Data Model – Study
Design Model (ODM-SDM)• Re-harmonization of HL7 Study Participation Message• Harmonization of MD Anderson/Nat’l Marrow Donor Program
(NMDP) Hematopoietic Cell Transplantation (HCT) project– Will add bone marrow/stem cell transplant concepts to BRIDG
• Updating BRIDG website and process documentation• Genzyme’s RegistryNXT!
– Will add rare disease registry concepts to BRIDG
• Nat’l Center for Research Resources’ Clinical and Translational Science Award (CTSA) Human Studies Database (HSDB) project
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Next Steps• Also in the summer:
– Harmonization of FDA’s Observational Medical Outcomes Partnership (OMOP) model
– HL7 CTR&R re-harmonization– NCI’s Clinical Trials Reporting Program (CTRP) re-
harmonization
• Fall:– Harmonization of CDISC Statistics model– Harmonization of more Hematopoietic Cell
Transplantation (HCT) concepts
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• BRIDG Project Home Page– www.bridgmodel.org
• SCC Contact Listserv– [email protected]
• BRIDG Users Listserv– [email protected]
• RCRIM: BRIDG as a DAM Listserv– [email protected]
Contact Information
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Q & A
Back up slides
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BRIDG Board of Directors
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Appointed Members Stakeholder
Charlie Mead NCI
Bron Kisler CDISC
Chuck Jaffe HL7
Jonathan Levine FDA
At Large Members Term Expiration
Jack Jones 2011
Becky Kush* 2011
Cecil Lynch 2012
AbdulMalik Shakir 2012
Sue Dubman 2013
John Speakman 2013
Diane Wold 2013
* ChairMitra Rocca FDA Ex Officio
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Semantic Coordination Committee
Name Affiliation
Charlie Mead NCI
Becky Angeles NCI / ScenPro, Inc.
Smita Hastak NCI / ScenPro, Inc.
Steve Sandberg NCI / ScenPro, Inc.
Wendy Ver Hoef NCI / ScenPro, Inc.
Julie Evans CDISC
Lloyd McKenzie NCI / Gordon Point Informatics
Mike Woodcock NCI / Mayo Clinic
