1. Clinical Research, the Sequence 2. Clinical Research Personnel (CRC, CRA, CFE) and Resource Utilization 3. Role of Technology Based Solutions in Private Practice 4. Types of Clinical Research Methodology (inductive/deductive designs); case series, retrospective review, prospective work, power analysis) 5. Regulatory Oversight 6. Sponsor Relationships 7. The Audit and Monitoring Site Visit 8.

Adapting Day to Day Clinical Workflow for Clinical Research 9. Meeting Research Related Expectations 10. Publication and Authorship 11. Winning the Work 12. Role of the National Principal Investigator (PI) 13. Role of the research site Principal Investigator (PI) 14. The Clinic Research Coordinator (CRC) 15. The Clinical Research Assistant (CRA) 16.

CRF (Case Report Forms) 17. Site qualification forms (SQF) 18. Clinical Trial Agreement (CTA) considerations 19. Investigational Review Board considerations 20. Study Budget Considerations 21. Site Budget Considerations 22. The Trial Master File (TMF) 23. Research Funding 24.

Research Ethics 25. Statistical Analysis Methodologies in Clinica Research (ITT vs MITT) 26. Remote Data Acquisition and Monitoring 27. Research Monitoring Considerations 28. Considerations for selecting an EDC (Electronic Data Capture) 29. Research Liability 30. The Role of the Contract Research Organization (CRO).