RP12 ClinicalTrials.gov Registration and Results Reporting

Contents:

PURPOSE:

Clinicaltrials.gov is a publicly available registry and results database administered by the National Library of Medicine. This policy establishes the authority of the University to require compliance with the clinicaltrials.gov registration and reporting requirements established by the Centers for Medicare and Medicaid Services, the Food and Drug Administration, and the National Institutes of Health.  To maintain quality and consistency across the University, this policy extends to all clinicaltrials.gov registration and reporting for research performed at the University, including registration to fulfill requirements necessary to publish in journals following the International Committee of Medical Journal Editors recommendations and other journal requirements as well as voluntary registration.

POLICY:

Principal Investigators conducting University research are responsible for compliance with clinicaltrials.gov registration and reporting as required by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  Principal Investigators must also comply with the University’s internal determinations, expectations, and requirements for clinicaltrials.gov registration, results reporting, and record management.  

For investigator-initiated research, the University designates the role of Responsible Party to the University researcher considered the Principal Investigator (PI). The University is not the Responsible Party for a clinicaltrials.gov record. 

For Sponsor-initiated research, without further designation, the Responsible Party is the funding sponsor, which may be an industry sponsor or an investigator from another academic institution.  However, in some cases, the funding sponsor may designate the PI at the University as the Responsible Party following the requirements established in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85). 

In the event that the Responsible Party leaves the University or for whatever reason can no longer serve as the Responsible Party, the PI must transfer the registration and reporting obligations as directed by the Quality Assurance Program in the Office for Research Protections or the Research Quality Assurance program at the College of Medicine. If a Responsible Party is leaving the University, they must notify the Quality Assurance Program in the Office for Research Protections or the Research Quality Assurance program at the College of Medicine prior to departure. 

Compliance with University, CMS, FDA, and NIH requirements is monitored and enforced by the University through the Human Research Protections Program, which includes the Quality Assurance Program in the Office for Research Protections at University Park (for all University colleges and campuses except for the College of Medicine and the Pennsylvania College of Technology) and the Research Quality Assurance program at the College of Medicine (for the College of Medicine and Penn State Health and its components).

APPLICABILITY:

This policy applies to all University research (academic and clinical) and investigators, including faculty, staff, and students. 

NON-COMPLIANCE:

The Responsible Party is subject to the penalties that federal entities may impose and/or pursue as a consequence of non-compliance. Failure to comply with FDAAA requirements may result in financial penalties, withholding of federal funds, and other civil or criminal sanctions sought by the FDA. Failure to comply with NIH policy may result in the suspension or termination of the award for the individual, as well the suspension of funding for the institution, and non-compliance may be considered in the review of new funding applications. Failure to comply with CMS requirements can result in a lack of payment for a qualified research billing service and a need to refile the qualified research billing claim.   

Furthermore, the University may issue its own corrective actions and sanctions for non-compliance with this policy, including, but not limited to, withholding grant funds and/or withholding, suspending, or terminating IRB approval.

DEFINITIONS

Clinicaltrials.gov is a public registry developed by the National Library of Medicine as part of a mandate from the Food and Drug Administration Modernization Act and further enhanced to include a results database as part of a mandate from FDAAA.

Investigator-initiated research is research using a protocol* developed and managed by the investigator.  

Sponsor-initiated research is research using a protocol* developed by the funding sponsor, which may be an industry sponsor or an investigator from another academic institution.

The Responsible Party is the entity or individual who is responsible for clinicaltrials.gov registration and reporting under federal law and NIH policy as well as under this University policy.

Principal Investigator (PI) is the investigator responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for the submission of clinical trial information.

*Protocols must be reviewed by the IRB.

FURTHER INFORMATION:

For information or questions, please contact the appropriate office based on your University affiliation.  Investigators from all University colleges and campuses except for the College of Medicine and the Pennsylvania College of Technology should contact the Quality Assurance program in the Office for Research Protections at orp-qm@psu.edu.  Investigators from the College of Medicine and Penn State Health and its components should contact Research Quality Assurance at clinicaltrials.gov@pennstatehealth.psu.edu. 

REFERENCES:

42 CFR 11: Clinical Trials Registration and Results Information Submission

Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (PL 110-85): Expanded Clinical Trial Registry Data Bank 

NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information

Centers for Medicare and Medicaid Services (CMS): CMS Manual System Transmittal 2955, Pub. 100-04 Medicare Claims Processing 

CROSS REFERENCES:

RA02 – Stewardship of Sponsored Programs

Most recent changes:

• September 1, 2023 - Updated Subject Matter Expert to Debra Thurley, Associate Vice President for Research.

Revision History (and effective dates) :

• March 18, 2022 - Updated to remove reference to Human Subjects Protections Office; updated ORP program name from Quality Management to Quality Assurance.
• March 24, 2020 - New Policy.