Simply registering a research study with ClinicalTrials.gov is not enough to comply with federal regulations and NIH policies. Responsible parties (PIs) of “Applicable Clinical Trials” or “NIH-funded clinical trials” are required to report both scientific and administrative information on trial outcomes no later than 1 year from the primary completion date.
This presentation will provide an overview of:
- ClinicalTrials.gov results reporting requirements
- Anticipating a delay in results submission –good cause extension
- Consequences for failure to comply with results reporting requirements
- How to prevent violations of federal regulations and NIH policies