United States National Library of Medicine National Institutes of Health

FAQ: ClinicalTrials.gov - Submitting Trial Information to ClinicalTrials.gov

A Protocol Registration System (PRS) account is required for submitting study information to ClinicalTrials.gov. Data submitters must coordinate with all of their partners so that trial information is submitted only once, by one of the entities listed below, to ClinicalTrials.gov.

Trial data may be submitted by the following entities:

Sponsors legally responsible for conducting clinical trials, e.g., holders of investigational new drug applications from the U.S. Food and Drug Administration.
Governmental or international agencies conducting or supporting clinical trials, e.g., the U.S. National Institutes of Health.
Lead principal investigators who are responsible for conducting and coordinating the overall clinical investigation across multiple study sites. Trial data should not be submitted from each individual study location.

If you meet the above criteria we invite you to submit data with the Protocol Registration System (PRS). The PRS account registration form and additional information, including a Guided Tour, is available at the PRS Information site at http://prsinfo.clinicaltrials.gov/

Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources

Last reviewed: 11 October 2006
Last updated: 11 October 2006
First published: 01 January 2001
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