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 (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  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.

The Quality Assurance Program supports investigators from all University colleges and campuses (except for the Pennsylvania College of Technology), whereas the Research Quality Assurance Program supports research conducted at the College of Medicine, the Penn State Health Milton S. Hershey Medical Center and other Penn State Health locations. These Research Quality (RQ) programs support researchers with registration and reporting, as well as monitoring investigator compliance with ClinicalTrials.gov federal and institutional requirements. Additionally, the Research Quality programs support and monitor investigator compliance with University, CMS, FDA, and NIH requirements.

APPLICABILITY:

This policy applies to all University research and investigators, including faculty, staff, and students. 

DEFINITIONS:

The definitions in this policy reflect those as defined by ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies that are most commonly used in reference to expectations for those who meet the role of Principal Investigator (PI) at Penn State. Per ClinicalTrials.gov definitions, a 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.

The definitions referenced below do not include all of the available ClinicalTrials.gov definitions which can be accessed directly for more information: PRS Users Guide.

ClinicalTrials.gov: 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 Title VIII of the Food and Drug Administration Amendments Act of 2007.

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

NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered.

Responsible Party: 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. At Penn State, in most cases, the Principal Investigator is considered the Responsible Party if the research is investigator-initiated.

PRS: The Protocol Registration and Results System is the online system that allows account holders within the institution to register, update, and report results on ClinicalTrials.gov. The PRS can be accessed at https://register.clinicaltrials.gov. At Penn State, there are two separate accounts: one for the College of Medicine and Penn State Health (Milton S. Hershey Medical Center), and one for University Park and the Commonwealth Campuses (Penn State University).

Sponsor: The entity (for example, corporation, agency, or institution) that initiates the study. 

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

*Protocols must be reviewed by the IRB.

POLICY:

A Principal Investigator (PI) conducting University research is responsible for being aware of and in compliance with ClinicalTrials.gov registration and reporting requirements (42 CFR Part 11) as required by the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH).  Additionally, PIs must also comply with the University’s internal determinations, expectations, and requirements for ClinicalTrials.gov registration, results reporting, and record management.  If per the applicable regulations, ClinicalTrials.gov registration is required, the HRPP may not approve proposed research until ClinicalTrials.gov registration is complete. The HRPP in consultation with the appropriate QA program will determine if an exception to the need for ClinicalTrials.gov registration prior to IRB approval is warranted.

As noted in the definition of Responsible Part, 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).

RESPONSIBILITIES OF UNIVERSITY PERSONNEL:

For all University Personnel regardless of location, the following responsibilities apply:

• Registration Requirement: Research projects that meet the definition of a clinical trial are required to be registered at the website ClinicalTrials.gov. See the Clinical Trial Registration Requirements and Records Management Standard Procedures. The Research Quality programs are able to offer registration and account management assistance for ClinicalTrials.gov. 
• Submitting Results: The Responsible Party (the PI) must submit trial results through ClinicalTrials.gov in accordance with the following timelines outlined in the Clinical Trial Registration Requirements and Records Management Standard Procedures.
• Consent Form Posting: Per the Revised Common Rule, a copy of an approved consent form used to enroll participants must be uploaded to ClinicalTrials.gov or a docket folder on Regulations.gov for all federally-funded research.
• University Departure: In the event that the Responsible Party leaves the University or can no longer serve as the Responsible Party, the PI must notify the appropriate Research Quality program and transfer the registration and reporting obligations prior to departure.

NONCOMPLIANCE:

The Responsible Party is subject to the penalties that federal entities may impose and/or pursue as a consequence of noncompliance. The QA program will follow the applicable standard procedures for handling instances of noncompliance, such as alerting the necessary University leadership. 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 as suspension of funding for the institution, and noncompliance may be considered in the review of future applications for funding. 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 noncompliance with this policy, including, but not limited to, withholding grant funds and/or withholding, suspending, or terminating IRB approval.

NOTICES OF NONCOMPLIANCE: 

Should an Investigator receive a “Preliminary Notice of Noncompliance (Pre-Notice) Letter” from Clinicaltrials.gov, they should immediately contact the appropriate Research Quality Program for assistance.

Should any investigator receive any notice related to ClinicalTrials.gov during an FDA inspection, they should immediately contact the appropriate Research Quality Program for assistance in responding.

FURTHER INFORMATION:

For more 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:

• April 24, 2024 - Updated "Purpose" and reorganized section order.  Added the following sections: "Applicability," "Responsibilities of University Personnel," and "Notices of Noncompliance." 

Revision History (and effective dates) :

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