Recently, there have been updates to ClinicalTrials.gov enforcement and various initiatives to drive transparency. Institutions are challenged to build robust compliance programs and individuals must be empowered to understand the regulations and learn helpful tips to lead their organizations.
This webinar reviews U.S. Food and Drug Administration (FDA) notices of noncompliance. The presenter discusses modernization of the Protocol Registration and Results System (PRS) which is used to register protocols and submit results to the ClinicalTrials.gov database. He also draws on his experience to identify common pitfalls to avoid noncompliance.
Clinical Research Coordinators, Clinical Researchers, Institutional Officials, Investigators, Sponsors
Meet the Presenter
Anthony Keyes, MBA, PMP – Johns Hopkins University
Tony directs the Johns Hopkins ClinicalTrials.gov Program and co-chairs the National Clinical Trial Registration and Results Reporting Taskforce. He has an MBA from the Johns Hopkins University and a Bachelors of Biology from the University of Maryland, College Park. He has 16 years’ experience in clinical trial management.