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.