Identify the laws, regulations, and standards to which clinical research sponsors are expected to comply, both in the United States and globally
Evaluate factual scenarios to identify compliance risks and develop strategies for responding to them
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.