ClinicalTrials.gov – a Three-Part Series

https://www.fda.gov/drugs/news-events-human-drugs/clinicaltrialsgov-three-part-series?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is announcing the availability of an on-demand, three-part series on ClinicalTrials.gov. In these webinars, the FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and requirements for submitting results. Participants will gain an understanding of the role and responsibilities of the CDER and with respect to ClinicalTrials.gov oversight. They will also hear examples of compliance and enforcement activities CDER has taken to encourage compliance. Topics Covered: FDA’s roles and responsibilities with respect to ClinicalTrials.gov oversight An overview of ClinicalTrials.gov definitions, laws, and regulations An overview of CDER’s compliance and enforcement activities with respect to ClinicalTrials.gov requirements, including case examples Additional Details: The webinar series is free, and no registration is required. The intended audience includes sponsors, sponsor-investigators and clinical investigators designated as responsible for submitting registration and results information to ClinicalTrials.gov.