It is not enough to just register a research study with ClinicalTrials.gov. The responsible party (PI) must also submit scientific and administrative information about the results of the trial. The person submitting results information to ClinicalTrials.gov must be very familiar with the study design and data analysis to accurately summarize the results information in compliance with federal regulations (section 801 of the Food and Drug Administration Amendments Act, FDAA 801) and the ClinicalTrials.gov review criteria.

This presentation will provide an overview of the purpose and guidelines for reporting results in ClinicalTrials.gov:

• Overview of ClinicalTrials.gov results database
• Purpose of results reporting
• Steps for submitting results of a clinical trial
• Editing and updating the record results
• PRS support, training material, and assistance
• ClinicalTrials.gov results information review process

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