How are recent legal and regulatory changes fundamentally affecting the clinical research enterprise? What do these changes mean to your institution's oversight of clinical research and efforts to promote the development of new technologies? Get answers to these questions and more as you examine the U.S. Department of Health and Human Services final rule on clinical trials reporting, the proposed 21st Century Cures Act, recent changes to HIPAA that allow for greater access to lab results, and the National Academies' call for a new regulatory framework. Join us to learn if so much change is warranted and what might be next.
Identify recently proposed and adopted legislative and regulatory initiatives affecting clinical research
Illustrate likely impact on current practices and evaluate importance of change
Evaluate whether further change is necessary or likely forthcoming