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Office of Research Compliance


Reporting Results

Deadlines

No later than one year after the trial’s primary completion date. Exceptions:

  • Trials involving FDA-regulated products and whose results will be used very soon for seeking FDA approval, licensure, or clearance can request a delay for up to two additional years. This will rarely apply to anything except industry-initiated trials.
  • Secondary outcome measures or additional adverse event information that is not collected by the primary completion date: Though the primary measures must still be reported by the one year deadline, these additional measures may be reported as follows:
    • Secondary outcomes: One year after the date on which the final subject is examined or receives an intervention for the purposes of final collection of data for the secondary outcome measure
    • Adverse events: One year after the date of data collection for the additional adverse event information
  • Extensions for good cause: The PI may request an extension of the deadline, prior to the date on which the results reporting would otherwise be due.
  • Waiver of results reporting for privacy or national security reasons

What Must Be Reported

Results are reported by completing four topic-specific modules. Almost all information must be entered in tabular format. Results cannot be reported by uploading publications. The PRS system provides numerous helpful documents and templates for each of the four results modules. The templates are especially useful, because they assist researchers in identifying and organizing the information needed by the PRS system.

Office of Research Compliance