Course Description

Most of the attention in negotiating clinical trial budgets and contracts is focused on fair compensation for the conduct of clinical research. Experience has shown however, that the greatest risk in such negotiations arise from rules and regulations outside Good Clinical Practice (GCP) that can result in heavy fines and penalties to the unwary. This web seminar will clarify these regulations and rules and provide practical direction on how to navigate these waters safely. 

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Learning Objectives

• Discuss the implications of Stark Law, Anti-Kickback Statute, False Claims Act and Medicare Secondary Payer Rule in clinical trial contracts and budgets negotiation
• Identify contract and budget risks and how to negotiate them safely
• Discuss creative processes to maximize revenue while minimizing risk
• Demonstrate skills with live exercises

Who Should Attend

• Research Managers
• Research Compliance Professionals
• Business Managers

Instructor

Robert Romanchuk, B.S.H.S., CIP, C.C.R.C., C.C.R.C.P.