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 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

4. Who is Responsible for Registering? Sponsor PI

5. Timing of Registration 21 days after 1 st patient is enrolled (PL 110-85) Prior to enrollment of 1 st 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:https://register.clinicaltrials.gov 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?