Clinicaltrials.gov Laurie A. Lebo, Ph.D. 2-7344.

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Presentation transcript:

Clinicaltrials.gov Laurie A. Lebo, Ph.D

What is ClinicalTrials.gov? A registry of federally and privately supported research studies conducted in the United States and around the world. A free service of the NIH, developed by the National Library of Medicine

Why Register? Public Law , Section 801 Involves human subjects Prospective Interventional Controlled Phase II-IV FDA regulated drug, biologic or device ICMJE Prospective Interventions (drugs, surgical procedures, devices, behavioral treatments, dietary interventions and process of care changes) to evaluate health outcomes Includes Phase I

Who is Responsible for Registering? Sponsor PI

Timing of Registration 21 days after 1 st patient is enrolled (PL ) Prior to enrollment of 1 st patient (ICMJE)

What if I don’t? Monetary penalties For Federally funded trials, withholding or recovery of grant funds Publishing

How to Register Contact Laurie Lebo to set up a PRS user name Log on to using the following information: Organization Name: Vanderbilt_University User Name: First letter of first name plus last name ex. LLebo Password:assigned by clinicaltrials.gov can be re-set by PRS administrator

Questions?