Clinical Trials Registration - University of Wisconsin–Madison

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FDA Requirements All Phase II-IV interventionaldrug, biologic or devicetrials. (Not Phase I trials.) Whether or not trial supportsa new FDA application <strong>Registration</strong> due 21 days after the first patientis enrolled4UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION
FDA Consequences Penalties for failure toregister or providing false ormisleading information Federally funded trials maybe penalized by withholding<strong>of</strong> funds Civil penalties $10,000 per violation After notification, up to $10,000 per day5UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION
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Clinical Trials Registration - University of Wisconsin–Madison

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