Reporting Requirements: Consequences for Noncompliance

Event Date: 

Mon, Apr 03, 2023 - 10:00am to 11:00am

Event Location: 


Simply registering a research study with 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:

  • 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.