Reporting Requirements for Studies With NIH/Federal FundingJul 16, 2021
Federally funded clinical trials (e.g. by NIH or VAORD) are generally required to submit results to ClinicalTrials.gov within one year of the primary completion date. Failure to do so can lead to denial of future funding for both the investigator and the university.
NIH's definition of a "clinical trial" is broader than you may think, and includes interventional, prospective human studies that study health-related outcomes, regardless of study size (e.g. Phase 1) or type of intervention (e.g. behavioral). Use their tool to identify if your study meets their definition.
The primary completion date is the last date a participant was examined or received an intervention for the purposes of data collection for the primary outcome measure. Usually, this is the last study visit date.
Clinical Research Support is here to help. Make sure to enter your grant number in the Secondary ID field in ClinicalTrials.gov so that we can assist you with reporting. Please email email@example.com with questions.