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
- Final date on which data was (or is expected to be) collected.
- Source: https://prsinfo.clinicaltrials.gov/definitions.html#PrimaryCompletionDate