Important Note: Primary Completion Date (PCD) is 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), whether the clinical study concluded according to the pre-specified protocol or was terminated. In the case of clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes.
Which studies need to submit results?
Results submission is required for:
- Clinical trials required to be registered per the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information
- Applicable Clinical Trials (ACTs) required to be registered per the Food and Drug Administration Amendments Act, Section 801 (FDAAA 801)
- Studies for which the grant and/or contract otherwise require results to be submitted
What is the deadline for submission of results?
NIH Policy and ACTs required to register:
- Initial results information (includes all primary outcomes) 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.
Is guidance available on the requirement to upload documents?
Results submissions for studies that have a Primary Completion Date on or after January 18, 2017 must include a copy of the protocol and the statistical analysis plan, which will be posted for public access.