ClinicalTrials.gov

Ensure compliance with ClinicalTrials.gov

ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The purpose of ClinicalTrials.gov is to provide information about clinical research studies to the public, researchers, and health care professionals.

ClinicalTrials.gov Header

What is ClinicalTrials.gov – background & regulatory mandate

ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997. FDAMA required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trial information for both federally and privately funded trials conducted under investigational new drug applications to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.

Following this mandate, the developed registry, ClinicalTrials.gov, was made public in 2000 to provide a platform for public and professional access to federally and privately funded trials. Expanded under the FDA Amendments Act of 2007, it now includes a results database, ensuring transparency and compliance with registration requirements.

The following studies require registration/results posting on ClinicalTrials.gov…

study type eligibility/mandate
Applicable Clinical Trials (ACT) Requires registration and results posting
NIH-funded Clinical Trials Requires registration and results posting
International Committee of Medical Journal Editors (ICMJE) ClinicalTrials.gov is one database that satisfies ICMJE registration requirements
Centers for Medicare & Medicaid Services (CMS) Requires registration for billing purposes

For more information on how to register your study, edit your study record, and submit results, click here to check out these PRS training guides.

How can we help?

In July 2023, the CTSI became the administrative home for UFCT-gov.  The CTSI UFCT-gov team can help with…

  • Reviewing research studies to determine applicability for registration on ClinicalTrials.gov
  • Determining applicability for required results posting
  • Facilitating registration, review and maintenance of ClinicalTrials.gov. submissions.

How does it work?

CT.gov checklist

getting started

ClinicalTrials.gov Registration Requirement Checklist

Determine eligibility for registration and keep track of requirements using this pdf guide. These tables are sourced from the University of Iowa and have been modified to be applicable to UF researchers.