Submitting Basic Results

When to submit Basic Results?

  • No later than 12 months after (Primary) Completion Date.
  • Primary Completion Date FDAAA [Required by for records first released on or after December 1, 2012]
    • Date that the final subject was examined or received an intervention for purposes of final data collection for the primary outcome, whether the trial concluded per protocol or was terminated.
    • Must keep this field accurate in ClincalTrials.gov since it’s how NIH determines the timeliness of basic results reporting
  • Study Completion Date