Clinton W. Brownley

1
BRIDGing CDASH to SASHow Harmonizing Clinical
Trial and Healthcare Standards May Impact SAS
Users

• Clinton W. Brownley
• American University
• Ph.D. candidate
• September 2, 2009

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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

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Obstacles to Harmonization

• Different Definitions and Vocabularies
• Different Protocols
• Electronic Data Management Systems that are Not
  Interoperable

4
CDISC Standards

• Operational Data Model (ODM)
• Study Data Tabulation Model (SDTM)
• Analysis Dataset Model (ADaM)
• define.xml (CRT-DDS)

5
CDISCs CDASH Project

• Clinical Data Acquisition Standards Harmonization
  (CDASH)
• Case Report Form (CRF) Content Standards based on
  SDTM Model
• Significant Positive Benefits

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CDISCs HLI Project

• Healthcare Link Initiative (HLI)
• Integration Standards
• Interoperability between Electronic Health
  Records (EHRs) and Clinical Research Systems
• Access EHR Data for Research Purposes

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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

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BRIDG Model

• Harmonize Clinical Trial and Healthcare Industry
  Models into Standard Protocol
• Unified Modeling Language (UML) Diagram
• Consistent with CDISCs ODM and HL7s RIM
• Semantic Interoperability among Databases
• Pilot Project Use Cases

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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

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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

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Conclusions

• Significant Positive Benefits
• Pilot Projects Demonstrate Feasibility
• Enables More Efficient, Effective Healthcare and
  Clinical Trial Research

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Questions?