Joint Clinical Trials Office

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Registering Studies and Submitting Results to ClinicalTrials.gov

ClinicalTrials.gov is a service of the U.S. National Institutes of Health that acts as a registry and results database of publicly and privately supported clinical studies of human participants. The Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE) all require the public registration of clinical trials. In particular, ICMJE, as a condition of publication, requires the public registration of "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." The HHS Final Rule also requires the public registration of clinical trials involving FDA-regulated products (excluding phase 1 trials or small feasibility device studies) to ClinicalTrials.gov, including the publication of results, to ClinicalTrials.gov. NIH Policy also requires the public registration of all clinical trials funded wholly or partially by NIH, to ClinicalTrials.gov, including the publication of results.

To find out how to register your studies, visit http://researchintegrity.weill.cornell.edu/clinicaltrialsdotgov.html or contact registerclinicaltrials@med.cornell.edu.

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Contact Information

Joint Clinical Trials Office Weill Cornell Medicine /
NewYork-Presbyterian
1300 York Avenue,
Box 305
New York, NY 10065 Phone: (646) 962-8215 Fax: (646) 962-0536

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