SOP: Results
Results Information Tip Sheet
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?
The general expectation is that each submission will include results information based on all data that have been collected and analyzed at the time of submission, with the following deadlines:
- Results information, including all primary and secondary outcome measures for which data collection is completed by the Primary Completion Date (PCD, defined above), is due 1 year after the PCD. This includes any associated statistical analyses.
- When data collection continues beyond the PCD for secondary outcome measures or adverse events, additional partial submissions may be required:
- Results information for each secondary outcome measure is due 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). Adverse event data collected between the PCD and the specific secondary outcome measure completion date must also be included.
- Results information for additional adverse event data collected after completion of secondary outcome measure data collection is due 1 year after the date on which the final subject is examined or receives an intervention for the purposes of final collection of adverse event data.
The Responsible Party should regularly evaluate when data were last collected for the primary outcome(s). If approaching 1 year since such data were most recently collected and further enrollment is unlikely, the study may well have already met its actual Primary Completion Date. Extensions for Good Cause must be submitted before one year from the actual Primary Completion Date. Prompt action would be necessary to meet the deadline for submission of results information or an Extension, as appropriate.
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.
How do I submit results?
Refer to How to Submit Your Results on ClinicalTrials.gov and to the SOP linked at the top of this page for further information. There is also an FAQ advising on how to enter results for terminated trials (i.e., stopped prematurely, but participants were enrolled).
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.