Clinical Research and the Law: Compliance Issues for Research Sponsors

  • Stark Law
  • Good clinical practice (GCP)
  • FCPA
  • False Claims Act
  • Conflicts of interest
  • Clinical trial agreements
  • Data sharing
  • Anti-Kickback Statute
  • International research
  • Contract research organizations
  • Medicare reimbursement

Learn to:


  1. Identify the laws, regulations, and standards to which clinical research sponsors are expected to comply, both in the United States and globally

  2. Evaluate factual scenarios to identify compliance risks and develop strategies for responding to them

  3. Assess the strengths and weaknesses of proposals to expand, reduce, or modify research sponsors’ compliance obligations


This course examines the responsibilities of life science companies and other entities responsible for the initiation, management, and/or financing of clinical trials in the United States, the European Union, and elsewhere in the world. Topics covered include good clinical practice (GCP) compliance, clinical trial agreements, clinical trial registration and results reporting, access to clinical trial data, managing conflicts of interest, reimbursement issues, and the implications of anti-bribery laws and U.S. fraud and abuse laws for clinical research.

Division of Online Learning

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