ClinicalTrials.gov Reporting Requirements: Consequences for Noncompliance [1]

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

Pre-registration is recommended. [2]