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 have results information submitted to ClinicalTrials.gov?
- 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 of 2007, Section 801 (FDAAA 801)
- Studies for which the grant and/or contract otherwise require results to be submitted
What is the standard results submission deadline for trials required to be registered under NIH Policy or FDAAA 801?
Results information, including for each pre-specified primary and secondary outcome measure, must be submitted no later than 1 year after the PCD (see above). When data collection continues beyond the primary completion date for secondary outcome measures and/or adverse events:
- Each secondary outcome measure 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 the secondary outcome measure (i.e., the completion date for the specific secondary outcome measure).
- Any additional adverse event information must be submitted no later than 1 year after the additional data are collected.
Do journals consider results information posted to ClinicalTrials.gov as prior publication?
The International Committee of Medical Journal Editors (ICMJE) expects authors to ensure that they have met the requirements of their funding and regulatory agencies regarding aggregate clinical trial results reporting in clinical trial registries. The ICMJE will not consider as prior publication the posting of trial results in ClinicalTrials.gov, which is limited to tables of trial participants enrolled, baseline characteristics, primary and secondary outcomes, and adverse events.
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. Refer to the Study Documents page for further information.