How To Negotiate Clinical Trial Contracts – Stark Rule, Anti-Kickback, and False Claims Act | Archived Recording| Romanchuk|

How To Negotiate Clinical Trial Contracts – Stark Rule, Anti-Kickback, and False Claims Act | Archived Recording| Romanchuk|

June 4th, 2013 // 12:08 am @

Available Upon Request – Certificate of Attendance for All Attendees to Fulfill Training Requirements
This webinar will give you a solid grasp of the regulations and statutes that anyone involved in clinical research contract negotiation has to know. You will discover how to negotiate and make clinical trial agreements that are federally compliant, thus avoiding any risk of regulatory action from FDA.


You would think that getting paid for doing a clinical trial would be simple, but there are many regulations and statutes in the US that can turn clinical trial contract negotiation into a real minefield. These regulations include:

  • The Stark Law
  • Anti-Kickback Statute
  • False Claims Act
  • Medicare Secondary Payer Rule

Every party who is involved in the negotiation process has to really know these rules well so that a fully compliant clinical trial contract is made. Any violations of these rules during clinical research can cause you major fines, penalties and other regulatory headaches.

This webinar is a 90 minute session that will provide you with a good grasp of these important clinical trial rules and how they affect clinical trial contracts, research and budgets. You will be able after this event to conduct an expert negotiation for a fully compliant clinical trial contract and will then be able to better manage all associated risks.


What You Will Learn:

  • Understand all implications of Stark Law, the AKS, FCA and MSPR on clinical trial contracts and payments.
  • Be able to fully identify contract and budget hot spots and how to manage them.
  • Create new processes that assure institutional compliance.
  • Demonstrate these skills in a simulated exercise

Who Should Attend:

  • Research Administrators
  • Clinical Research Contract professionals
  • Sponsor Contract Managers
  • Compliance professionals
  • All professionals involved in the business aspects of clinical research

About Your Speaker

Bob Romanchuk, is a clinical research professional with over a decade of experience in a broad range of clinical research infrastructure building, operation and management of both IRBs and research programs. This includes assembling and managing an IRB, building a cardiovascular research center for a large community hospital and creation and operation of a central research office for a 13 hospital system across North Carolina, South Carolina and Virginia. His certifications include CIP (Certified IRB Professional), CHRC (Certification in Health Research Compliance), CCRC (Certified Clinical Research Coordinator) and CCRCP (Certified Clinical Research Contract Professional). He has presented numerous times nationally on the subjects of clinical trial billing, human subjects protections and the creation and operation of centralized research offices.

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