New University Policy for ClinicalTrials.gov

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Office for Research Protections     |     Institutional Review Board (IRB)      |     Quality Management


 

The Office for Research Protections, in conjunction with Research Quality Assurance at the College of Medicine, announces the release of a new University policy, RP12: ClinicalTrials.gov Registration and Results Reporting.  Recently approved by President’s Council, this policy requires compliance with the ClinicalTrials.gov registration and reporting requirements established by the Food and Drug Administration, the National Institutes of Health, and the Centers for Medicare and Medicaid Services.  

A key component of the policy is that it assigns the Principal Investigator as the “Responsible Party” in ClinicalTrials.gov.  This clarifies that Penn State is not responsible for updating or maintaining an individual researcher’s records.  The Office for Research Protections at University Park assists researchers not affiliated with Penn State Health or the College of Medicine with registering and reporting in ClinicalTrials.gov. More information is available on the ORP’s Clinical Trials webpage.  Researchers at Penn State Health and the College of Medicine should contact Research Quality Assurance