Research Roundtable: ClinicalTrials.gov FAQ - Study Registration (Part 1)
Published January 16, 2024
ClinicalTrials.gov has an extensive FAQ section ranging from general to investigation-specific. This edition of “Research Roundtable” highlights a selected FAQ, “Study Registration.”
ClinicalTrials.gov is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and internationally. It has an extensive FAQ section ranging from general to investigation-specific. Many of these questions frequently arise at the University at Buffalo, primarily regarding either study registration or results posting. This edition of “Research Roundtable” highlights a selected FAQ, “Study Registration.” (This is part one of a two-part series on registration.)
How do I access ClinicalTrials.gov at UB?
ClinicalTrials.gov uses a web-based data entry system called the Protocol Registration and Results System (PRS) to register clinical studies and to submit results information for registered studies. ClinicalTrials.gov establishes one PRS account for an organization (university or medical center). UB’s ClinicalTrials.gov account is SUNYBuffalo. The Investigator Affiliation should be listed as the State University of New York at Buffalo. Once your study is made public on ClinicalTrials.gov, it will remain on the website permanently. If you leave UB at any time, you will need to provide your future contact information to the UB ClinicalTrials.gov administrators so that the change is made in the ClinicalTrials.gov study information.
You can contact a UB PRS Administrator to request a user login at UBClinicalTrialsgov@buffalo.edu.
Which trials must be registered on ClinicalTrials.gov?
Note: Registration requirements vary depending on the law, policy, funder, and/or study type.
Registration is required for NIH-funded clinical trials (NIH Policy).
All clinical trials funded in whole or in part by NIH require registration and results reporting. All interventional trials are included in this policy, even those that are not considered to be ACTs, such as behavioral, surgical, phase 1 drug, and feasibility device studies. See more at NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.
Registration is required for most Applicable Clinical Trials (FDAAA Law).
Applicable Clinical Trials (ACT) need to be registered, including drugs, biologics, and devices. There are some exclusions, i.e., Phase 1 drug trials, small clinical trials to determine the feasibility of a device, behavioral interventions, and non-interventional studies. See more at Which Trials Must Be Registered.
Registration is required for publishing in certain journals (ICMJE Policy).
Clinical trials being considered for publication in International Committee of Medical Journal Editors (ICMJE) affiliated journals must be registered on ClinicalTrials.gov. For more information, see which journals follow the ICMJE Recommendations.
Registration is required for billing centers for Medicare and Medicaid Services (CMS).
Registration in ClinicalTrials.gov is required for all “Qualifying Trials,” meaning clinical trials that are qualified for coverage as specified in the "Medicare National Coverage Determination (NCD) Manual, Section 310.1.” The National Clinical Trial (NCT) Number that is assigned by ClinicalTrials.gov must be included on all hospital and professional claims for related items/services. See more on Medicare and Medicaid Services (CMS) billing requirements.
Registration is required for clinical trials supported by National Cancer Institute (NCI).
See more at NCI Clinical Trial Access Policy.
Registration is required for research projects funded by Patient-Centered Outcomes Research Institute (PCORI).
See more at PCORI Process for Peer Review and Public Release of Research Findings.
When do I need to register my study on ClinicalTrials.gov?
If you plan on publishing your study results, it is highly recommended that you register prior to the first subject enrollment (study must have an NCT number) due to ICMJE policy. Below are registration and results reporting timelines:
FDAAA Law | NIH Policy | ICMJE Policy | CMS | |
Scope | Applicable Clinical Trials (ACT) | All NIH-funded Trials (human subjects only) | Interventional Clinical Trials | Qualifying Clinical Trials |
When to Register | No later than 21 days of enrollment of the first subject | No later than 21 days of enrollment of the first subject | Prior to first subject enrollment | Prior to claims submitted to Medicare |
Results Reporting | No later than 12 months after the Primary Completion Date (the last subject last visit) | No later than 12 months after the Primary Completion Date (the last subject last visit) | Not required | Not required |
How can I get help related to ClinicalTrials.gov at UB?
The UB ClinicalTrials.gov team offers continuous support to UB investigators who need assistance with account setup or have questions with registering their trial and/or entering the results into the ClinicalTrials.gov repository. For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team (UBClinicalTrialsgov@buffalo.edu) or ClinicalTrials.gov Protocol Registration and Results System Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.
Watch for part two of “ClinicalTrials.gov FAQ — Study Registration” in an upcoming edition of “Research Roundtable.”
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