Results Submission

The Primary Completion Date (PCD) of a study 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(s).

Which studies need to submit results?

Results submission is required for:

  • Studies subject to the NIH Policy.
  • ACTs for which the studied product is approved, licensed, or cleared by FDA by the PCD.
  • ACTs for which the studied product is not approved, licensed, or cleared by FDA by the PCD, only if the PCD is on or after January 18, 2017.
  • Studies for which the grant and/or contract otherwise require results to be submitted.

What is the deadline for submission of results?

ACTs and studies subject to the NIH Policy:

  • Initial results information must be submitted no later than 1 year after the PCD.
  • Secondary outcome measure data must be submitted no later than 1 year after the date on which the final subject is examined or receives an intervention for the purposes of final collection of data for a secondary outcome measure.
  • Any additional adverse event data must be submitted no later than 1 year after the date of collection of this information.

For studies that are neither ACTs nor subject to the NIH Policy, refer to the grant and/or contract.