ClinicalTrials.gov – a Three-Part Series

DATE

On Demand

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

In a three-part webinar series, FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements. Participants will gain an understanding of CDER’s role and responsibilities with respect to ClinicalTrials.gov oversight and will hear examples of compliance and enforcement activities CDER has taken to encourage compliance.

INTENDED AUDIENCE

• Sponsors, sponsor-investigators and clinical investigators designated as responsible for submitting registration and results information to ClinicalTrials.gov

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

FDA RESOURCES

• FDA's Role: ClinicalTrials.gov Information

Topics & Presentations	Speakers
ClinicalTrials.gov: Part 1
Meeting Transparency and Reporting Requirements.pdf	Miah Jung, Pharm.D. Supervisory Pharmacologist Division of Enforcement and Postmarketing Safety (DEPS) | Office of Scientific Investigations (OSI) | Office of Compliance (OC) | Center for Drug Evaluation and Research (CDER) | FDA
ClinicalTrials.gov: Part 2
Definitions, Laws, and Regulations.pdf	Jan Hewett, J.D. Regulatory Counsel Policy Office (PO) | OSI | OC | CDER | FDA
ClinicalTrials.gov: Part 3
CDER’s Compliance and Enforcement Activities.pdf	Rachelle Swann, Pharm.D. Lead Pharmacologist DEPS | OSI | OC | CDER | FDA