Research Roundtable: ClinicalTrials.gov FAQ — Results Reporting (Part 1)

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” is part one of a two-part series that highlights a selected FAQ, “Results Reporting.” 

1. Applicable Clinical Trials (ACT) per Food and Drug Administration Amendments Act of 2007 (FDAAA), including:

• Trials of drug/biological products: Controlled, clinical investigations of a product subject to FDA regulations
• Trials of devices: Prospective controlled trials with health outcomes comparing a device against a control

Note that an ACT requirement must also meet one of the following:

• Trial has one site in the U.S.
• Trial is conducted under FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE)
• Trial involves a drug, biologic, or device that is manufactured in the U.S. and is exported for research

Excluded from this requirement per FDAAA are:

• Phase 1 drug trials
• Small clinical trials to determine the feasibility of a device
• Trials that do not include drugs, biologics, or devices (e.g., behavioral interventions)
• Non-interventional (observational) clinical research

2. All NIH-Funded Clinical Trials including studies with human subjects prospectively assigned to one or more interventions to evaluate the effects of interventions on health-related biomedical or behavioral outcomes.

Excluded from this requirement per NIH are studies intended solely to refine measures and studies that involve secondary research with biological specimens or health information.

The timeline for the FDAAA and the NIH Policy for submitting results information is no later than one year after the trial’s Primary Completion Date, which is the date that the final subject was examined, or received an intervention, for the purposes of final collection of data for the primary outcome.  

Step-by-step instructions for submitting Results information into the ClinicalTrials.gov Protocol Registration and Results System (PRS) is provided in PRS Guided Tutorials.

FDA noncompliance with ClinicalTrials.gov registration and results reporting may result in fines, currently more than $14,000 per study/per day, for PIs and their institutions. Pre-notices may be issued for potential violations. For an NIH-funded study for which a grantee is the responsible party, failure to submit required results information could result in NIH not releasing remaining funding for a grant or funding for a future grant.

A request can be made to delay the submission of results information by submitting a “good cause extension” via the PRS prior to the date that results information would be due.

Records that have a National Clinical Trial (NCT) number cannot be deleted. If no participants were ever enrolled in the trial, the “Overall Recruitment Status” can be set to “Withdrawn” and no results information will need to be submitted. ACTs and NIH-funded trials that terminate prematurely but have enrolled participants and collected data must report results on ClinicalTrials.gov. 

For ACTs, NIH-funded trials, and voluntary trial submissions that are required to be registered, the responsible party's obligation to submit updates ends when all required clinical trial results information has been submitted and the responsible party has made all corrections and/or addressed all concerns in response to any notice received from PRS.

For UB assistance with ClinicalTrials.gov registration and reporting requirements, contact the UB ClinicalTrials.gov team (UBClinicalTrialsgov@buffalo.edu) or ClinicalTrials.gov PRS 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 — Results Reporting” in an upcoming edition of “Research Roundtable.”

“Research Roundtable” is a section in the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter. Add your email to the newsletter mailing list here.