1. YALE MASTER SLIDE HERE Clinical Research Management – Is not just a handshake deal? Jamie Caldwell, MBA Director Office of Research Services for the Health Sciences Loyola University Chicago at the Medical Center

2. Why Clinical Research? Researchers conduct clinical studies, with the help of volunteers, to answer specific questions about prevention, diagnosis and treatment of disease. Clinical research, assist with efforts to make health care better. Access to investigational drugs and procedures before they are otherwise available. Working together, we can answer questions that will lead to medical breakthroughs and better health for the future.

3. What is the process? The Drug Development Process Statistical Concepts for Clinical Research Fundamentals of Site Management Fundamentals of Clinical Monitoring Good Clinical Practices

4. Clinical Research Management

5. Why do clinical research? From an Institutional Perspective Distinguishes institution and supports an academic approach to providing care Cutting edge patient care and lead to increased referrals Pays well Supports infrastructure Reduces patient expenses

6. Background/Rationale Goal: Enhance revenues by becoming a preferred site among sponsors. Operational efficiencies to speed time from contract initiation to study enrollment. Coordination necessary between many different parties to ensure compliance (IRB, protocol development, billing).

7. Understanding the Environment Clinical Investigator Study Coordinator Pharmacy Grant Accounting Office Research Administration Office Sponsor CRO Financial Services Audit Team

8. Still Hot Button Issues Elements of Informed Consent Clinical Trial Agreements Role of the Clinical Trial Agreement Research Compliance Billing Compliance Still Hot Button Issues

9. Billing and Collection Process The Billing and Collection Process at Academic Medical Centers (AMC’s) is still a major concern for many administrators who are responsible for the bottom line.

10. Signs of a Successful Clinical Research Program Strong Research Administration –Contracting and budgeting experience –Fully staffed offices –Rapid process –Flexibility Training Programs –Training at all levels from the investigator to front desk personnel Support Services –Research pharmacy, clinical trials office, dedicated research space, centralized coordinator support