1. CLINTON W. BROWNLEY AMERICAN UNIVERSITY PH.D. CANDIDATE SEPTEMBER 2, 2009 BRIDGing CDASH to SAS: How Harmonizing Clinical Trial and Healthcare Standards May Impact SAS Users

2. 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

3. 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

6. 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

7. 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

8. 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

9. 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

10. 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

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

12. Questions?