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CLINTON W. BROWNLEYAMERICAN UNIVERSITY
PH.D. CANDIDATESEPTEMBER 2, 2009
BRIDGing CDASH to SAS:How Harmonizing Clinical Trial and Healthcare
Standards May Impact SAS Users
Presentation Outline
• Obstacles to Harmonization
• Clinical Data Interchange Standards Consortium (CDISC)
• Health Level Seven (HL7)
• Biomedical Research Integrated Domain Group (BRIDG)
• Benefits of Harmonization
• Conclusions
Obstacles to Harmonization
• Different Definitions and Vocabularies
• Different Protocols
• Electronic Data Management Systems that are Not Interoperable
CDISC Standards
• Operational Data Model (ODM)
• Study Data Tabulation Model (SDTM)
• Analysis Dataset Model (ADaM)
• define.xml (CRT-DDS)
CDISC’s CDASH Project
• Clinical Data Acquisition Standards Harmonization (CDASH)
• Case Report Form (CRF) Content Standards based on SDTM Model
• Significant Positive Benefits
CDISC’s HLI Project
• Healthcare Link Initiative (HLI)
• Integration Standards
• Interoperability between Electronic Health Records (EHRs) and Clinical Research Systems
• Access EHR Data for Research Purposes
HL7 Model
• Reference Information Model (RIM)
• Regulated Clinical Research Information Management (RCRIM) Working Group
• MOU agreement with CDISC
• Harmonize all CDISC and HL7 RCRIM standards with the RIM via the BRIDG Model
BRIDG Model
• Harmonize Clinical Trial and Healthcare Industry Models into Standard Protocol
• Unified Modeling Language (UML) Diagram
• Consistent with CDISC’s ODM and HL7’s RIM
• Semantic Interoperability among Databases
• Pilot Project Use Cases
Benefits of Harmonization I
• Minimizes Double Data Entry
• Reduces Inefficiencies of Manual Data Manipulation
• Reduces Chance of Errors
• Reduces Start-Up Time and Resources
• Improves Data Quality and Integrity
Benefits of Harmonization II
• Interoperability between EHRs and CRFs
• Process and Analysis Automation
• Researchers Work on Value-Generating Tasks
• Regulators Review Submissions More Efficiently
• Develop Standard Software Programs and Macros
Conclusions
• Significant Positive Benefits
• Pilot Projects Demonstrate Feasibility
• Enables More Efficient, Effective Healthcare and Clinical Trial Research
Questions?