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Acceptance criteria is given below. This same information can be found at: http://www.nlm.nih.gov/services/ctgetfaq.html.

You will need a Protocol Registration System (PRS) account to submit study information to ClinicalTrials.gov. You may submit trial data if you are a:

  • - Sponsor legally responsible for carrying out clinical trials, e.g., holders of investigational new drug applications from the U.S. Food and Drug Administration.
  • - Governmental or international agency carrying out or supporting clinical trials, e.g., the U.S. National Institutes of Health.
  • - Lead principal investigator who is responsible for carrying out and coordinating the overall clinical investigation across multiple study sites. Trial data should not be submitted from each individual study location.

You must coordinate with all of your partners to make sure that trial information is submitted only once.

If you meet the above criteria, you may submit your data by registering with the Protocol Registration System (PRS). You can find the PRS account registration form, a guided tour and additional information at the PRS Information site.