Clinical Trials Registration - University of Wisconsin–Madison

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Introduction2 Clinical trials registration in ClincialTrials.gov isrequired. UW-Madison wants to ensure that trials areappropriately registered. Failure to register can have severeconsequences. Investigators may have been unaware of theserequirements. Newly developed procedures and guidelinesshould help.UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION
FDA Requirements All Phase II-IV interventionaldrug, biologic or devicetrials. (Not Phase I trials.) Whether or not trial supportsa new FDA application Registration due 21 days after the first patientis enrolled3UW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION
Page 1: Clinical Trials Registration:Your O
Page 5 and 6: FDA Consequences Penalties for fail
Page 7 and 8: International Committee of Medical
Page 9 and 10: Comm. on Clinical Trials Registrati
Page 11 and 12: Registering trials on ClinicalTrial
Page 23 and 24: Websitewww.grad.wisc.edu/research/h
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Clinical Trials Registration - University of Wisconsin–Madison

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