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?