What specific information must be provided to ClinicalTrials.gov?

Federal regulations require that applicable clinical trials and NIH-funded clinical trials be registered no later than 21 days after enrollment of the first participant. However, researchers should be aware that ICMJE requires registration prior to enrollment of any subjects, and member journals may decline publication articles from studies that were not registered in accordance with this requirement.After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, one IRB-approved informed consent form used to enroll subjects must be posted to Cliniclatrials.gov.

Results from clinical trials must be reported to ClinicalTrials.gov no later than 12 months after the primary completion date. The primary completion date is defined as the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated.

For clinical trials initiated on or after January 18, 2017, information submitted to ClinicalTrials.gov must be updated at least once every 12 months.