Downloadable table offers comprehensive ClinicalTrials.gov guidance
Graphic courtesy of the National Library of Medicine; originally created for the "Musings from the Mezzanine" blog.
Published September 4, 2024
While policies and regulations on ClinicalTrials.gov registration and reporting aim to increase the availability of information to the public about clinical trials, requirements vary depending on the law, policy, funder, and/or study type. Consequently, researchers and administrators alike frequently struggle with the scope and definitions of what constitutes a clinical trial and whether to register their study and/or report study-related results.
University at Buffalo ClinicalTrials.gov administrators have developed a table that summarizes the registration and reporting requirements as they relate to federal regulation (FDAAA 801), a complementary NIH policy, and publishing in medical journals (ICMJE), while also providing relevant links to original resources. The table — available as a PDF download and also viewable below — is designed to serve as a quick and comprehensive guide to assist investigators in decision-making about their study and its registration and reporting requirements.
UB Clinical and Translational Science Institute (CTSI) Hub Liaison Team Associate Director Andrew Talal, MD, MPH, Professor of Medicine, Jacobs School of Medicine and Biomedical Sciences, believes it is essential for investigators to take advantage of the ClinicalTrials.gov guidance tools and resources available at UB.
“I believe that guides such as this registration and reporting requirements table can be quite useful in orienting new physician-scientists about whether clinical trials registration is required,” Talal says. “However, if there is any question, it is always better to register the research because the penalties for not doing so when required can be quite stiff.”
UB CTSI Associate Director Sanjay Sethi, MD, Assistant Vice President for Health Sciences; Professor and Chief, Pulmonary, Critical Care and Sleep Medicine, Department of Medicine, Jacobs School; and Director of UB’s Clinical Research Office, adds that the focus for research teams should be on best practices and clinical trial transparency.
“Prior to ClinicalTrials.gov, results of trials that did not match expectations were often not made public,” Sethi explains. “The time and effort it takes to report results on ClinicalTrials.gov is worth it because it fosters transparency in clinical research, prevents redundant studies, and is a valuable resource for patients.”
See below for the CTSI ClinicalTrials.gov Registration and Reporting Requirements Summary Table:
| FDAAA 801 | NIH | ICMJE | |
| Definition and Scope of “Clinical Trial” | Interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices
| A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes
| Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes
|
| Studies Requiring Registration | Applicable Clinical Trials (ACT) regulated by the US FDA
| Clinical trials that are partially or fully funded by the NIH, regardless of whether the trial involves an FDA regulated product | Applies to clinical trials where the intention is to publish in an ICMJE member journal
|
| Studies Not Requiring Registration |
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| Registration Requirement | No later than 21 days after enrollment of the first participant – see here | No later than 21 days after enrollment of the first participant - see here | At or before the first patient is enrolled in the study – see here |
| Results Reporting Requirement | No later than 12 months from the study completion date – see here | No later than 12 months after the study’s primary completion date – see here | Results reporting is not required |
| Penalties |
| Loss of current or future NIH funding | Refusal to publish in ICMJE journals |
Note that the document entitled “ClinicalTrials.gov Registration and Reporting Requirements Summary Guide” is posted on the CTSI website and available by request from UB ClinicalTrials.gov administrators.
For additional 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 (PRS) Administrators Lynn Jagodzinski (lynnjago@buffalo.edu), CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi (uj@buffalo.edu), CTSI Quality Assurance Specialist.
And for more information on recent updates to ClinicalTrials.gov, check out recent CTSI Translational Spotlight stories highlighting the importance of compliance, recent modernization efforts, and, in the newsletter's "Research Roundtable" section, helpful FAQs.