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Clinicaltrials

Clinicaltrials.gov. Laurie A. Lebo, Ph.D. Laurie.Lebo@vanderbilt.edu 2-7344. What is ClinicalTrials.gov?. A registry of federally and privately supported research studies conducted in the United States and around the world.

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Clinicaltrials

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  1. Clinicaltrials.gov Laurie A. Lebo, Ph.D. Laurie.Lebo@vanderbilt.edu 2-7344

  2. 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 www.clinicaltrials.gov

  3. Why Register? Public Law 110-85, Section 801 ICMJE Prospective Interventions (drugs, surgical procedures, devices, behavioral treatments, dietary interventions and process of care changes) to evaluate health outcomes Includes Phase I • Involves human subjects • Prospective • Interventional • Controlled • Phase II-IV • FDA regulated drug, biologic or device

  4. Who is Responsible for Registering? • Sponsor • PI

  5. Timing of Registration • 21 days after 1st patient is enrolled (PL 110-85) • Prior to enrollment of 1st patient (ICMJE)

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

  7. How to Register • Contact Laurie Lebo to set up a PRS user name • Log on to https://register.clinicaltrials.gov 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

  8. Questions?

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