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TGH Guidelines for NCT registration on clinicaltrials.gov

Registration on The Clinical Trials govenment website is required for all studies that involve a study budget with patient charges.  Upon completion of the registration process, the National Clinical Trial (NCT) number will be assigned to all medical bills.  The format for the ClinicalTrials.gov registry is 'NCT' followed by an 8-digit number, e.g.: NCT00000419.  For sponsored trials, the study is usually registered by the sponsor.  For PI initiated studies, the study needs to be registered by the study coordinator or PI. If a study meets one of the following criteria, is should be registered:

  • Funded by NIH, CDC, AHRQ, CMS, DOD, or VA
  • Conducted under an investigational new drug application (IND) or investigational device (IDE), reviewed by the FDA
  • Related to coverage with evidence development. Click here for the Medicare definition.
  • Defined as a clinical trial or study.  See Medicare Guidelines below for clinical trial definition.

Process for clinicaltrials.gov registration For sponsored studies, please contact the sponsor to obtain the NCT nuber.

  1. Apply for a PRS (protocol registration system) account on Clinical Trials government website.
  2. Clinicaltrials.gov will send a contact request and the PRS administrator will accept the request. a. This will be done by either the TGH contact or the USF contact, depending on the PI’s affiliation.
  3. An email will be generated by clinical trials, providing a login.
  4. Log in to the website and answer the required questions to register the study.
  5. If revisions are required, you will receive an email stating such. Complete the requested revisions and re-submit.
  6. Once you receive confirmation that the study will be published, log back into the site to retrieve the assigned NCT number.

Medicare Guidelines for NCT registration | Additional Justification for Study Registration