ComplianceOnline, Online Event
2013-01-10
Why Should You Attend: Payment for work done in the execution of a clinical trial would seem to be a straightforward proposition, but in the U.S. a multitude of regulations and statutes and their associated risk can turn contract and budget negotiation into a minefield. Such regulations include the Stark Law, the Anti-kickback Statute, the False Claims Act and Medicare Secondary Payer Rule. All parties involved in the clinical research contract negotiation process must be well versed in these rules in order to create federally complaint agreements and thus avoid the risk associated with violations.
Violations of these rules in the course of clinical research have resulted in heavy fines and penalties for well known and respected institutions.
This 90-minute session will provide a basic understanding of these rules and how they impact clinical research contracts and budgets. The knowledge gained from this training will allow participants and their institutions to expertly negotiate compliant contracts and thus better manage the associated risk. By attending this training, you will not only be well informed, but learn how to implement practical, workable solutions and negotiate risk-free clinical trial contracts. Learning Objectives: At the end of this session, attendees will be able to: - Recount the implications of Stark Law, the AKS, FCA and MSPR on clinical trial contracts and payments.
- Identify contract and budget hot spots and how to manage them.
- Create processes that assure institutional compliance.
- Demonstrate these skills with a live case exercise.
Areas Covered in the Seminar: - Stark Law and Clinical Research.
- The Anti-kickback Statute (AKS) and its implications.
- The False Claims Act (FCA) and clinical trial billing.
- The Medicare Secondary Payer Rule (MSPR) and its impact on clinical research contracts.
- Contract and Budget hot spots.
- Processes for compliance and risk mitigation.
- Case exercise.
Who Will Benefit: This webinar will provide valuable assistance to all personnel involved in the research enterprise, including: - Research Administrators
- Clinical Research Contract professionals
- Sponsor Contract Managers
- Compliance professionals
- All professionals involved in the business aspects of clinical research
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Invited Speakers:
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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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