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When Do Results Need to Be Reported?

FDAAA requires reporting of study results for Applicable Clinical Trials no later than 12 months after the date of final data collection for the primary outcome measure, referred to as the Primary Completion Date.

Reporting of results can be delayed beyond the 12-month required timeline if:

  • The trial is of a drug or device that has not been approved for marketing by the FDA for any indication;
  • Result reporting will be required within 30 days of initial approval;
  • The trial is of a drug or device for which the manufacturer has filed or is preparing to file an application seeking approval of the new use studied in the trial; or
  • A request for delay that "demonstrates good cause" has been granted by the Director of the NIH.
Note: Per FDAAA, sponsors must also include study results in the registry. The results submissions should include lay language summaries of subject demographics and characteristics, primary and secondary outcomes, and disclosures of any privacy agreements. Timelines for this information are set forth (see related links below). At this time, the ICMJE does not require the recording of study results in the ClinicalTrials.gov database. Dartmouth recommends that PIs stay informed about these requirements, as they evolve.
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