Basic Discovery

3. A Fragmented System with Silos and Barriers Global Health: Service/ Research, Population/ Publication Community Assessment Care delivery Outcomes Economics Basic Discovery Preclinical Research; In Vivo Analysis Proof of Concept in Man Improve Community Health Status Clinical Development Phase II, III FDA Approval Evidence Based Medicine Practice Adoption, Practice Guidelines, Cost Effective PK,PD, Toxicology Translation and Adoption Discovery Translation Global Health Clinical Research Current State Entities HCS/Hospitals/ Practices/FQHC/AHS Public Health/Government/ NGOs Clinical Research Organizations/AHS AHS/Industry/ Biotech Industry/Biotech Timeline ? 15-20 years

4. Seamless Integration Global Health: Service/ Research, Population/ Publication Community Assessment Care delivery Outcomes Economics Basic Discovery Preclinical Research; In Vivo Analysis Proof of Concept in Man Improve Community Health Status Clinical Development Phase II, III FDA Approval Evidence Based Medicine Practice Adoption, Practice Guidelines, Cost Effective PK,PD, Toxicology Translation and Adoption Discovery Translation Global Health Clinical Research HCS/Hospitals/ Practices/FQHC/AHS Public Health/Government/ NGOs Clinical Research Organizations/AHS AHS/Industry/ Biotech Industry/Biotech AMC/AHS AMC/AHS AMC/AHS AMC/AHS AMC/AHS AMC/AHS Health Service and Outcomes Research Preclinical Research Global Health Research and Service Guidelines And Adoption Basic Discovery Proof of Concept In Man Community Health Trends PD/PK/ Toxicology Phase II, III and IV ? DCCR DCRI DTRI DGHI New Timeline ????

5. The problems • Multiple sponsors and multiple systems • Duplication of data entry efforts • Adverse event reports • Billing compliance

6. Integrating EHR and EDC • Semantic Web approach • vocabularies are still far from converging • links between databases with a reduced effort • What we are doing • pilot project focusing only on socio-demographic and co-morbidities data • Duke cardiovascular database and Society of Thoracic Surgeons • partnership with NC State and UNC

7. A Layered Approach A layered approach to the Semantic Web A “layered model” of the semantic web – basics of knowledge network

8. Data Quality Management

9. Data Quality Management Data Quality Methodology

10. Master project and subject index • Overlay index to cover eIRB and projects in the basic sciences • Relates to master subject index • Billing compliance

11. Enterprise-level Clinical Trial Management System

12. Data security • Authentication • Secure data transfer • Durham • Kannapolis • Singapore • Making data available to patients and providers

13. Decision Support Repository • 13 administrative databases • Web interface where researchers can search through data dictionaries and minimal data quality indices • Ability to query based on inclusion and exclusion criteria to evaluate number of potential subjects eligible for trial

14. Marketing Operational Clinical Research Balanced Scorecard Adverse Events Prospective Medicine Competitive Market Share Outcome Analysis Productivity Genomic Patient Satisfaction Clinical Trials Patient Safety LEAN Six Sigma Education Orders Meditech Financial IDX SMS Cost Volume Census Information Domain

15. Patient Health Record

16. Patient Health Record

17. Patient Health Record

18. Summary