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Research Services Overview

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
How Can We help?
How Does it work?
Helpful resources
Leaving UF?

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?

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.
  • Providing a SANDBOX environment. See below.

ClinicalTrials.gov does not offer a public “demo account” or SANDBOX environment to practice data entry.  Our team can make one available to UF users if they send us a request and the following information:

  • Full Name
  • Requested User Login Name
  • UF email address
  • Requested Temporary Password

This SANDBOX will allow users to familiarize themselves with CT.gov record registration and data upload in both “Classic” and “Modern View”.  This will greatly enhance the use of the guided tutorials on the ClinicalTrials.gov website available at https://clinicaltrials.gov/submit-studies/prs-help

Request should be sent to our team at:  UFCT-gov@ufl.edu

How does it work?

Flowchart showing the ClinicalTrials.gov registration review process. Step 1: “Submit to IRB” – The process begins with submission of the study to the Institutional Review Board (IRB). Step 2: “Ancillary Review” – Upon IRB submission, UFCT-gov conducts a review to determine whether ClinicalTrials.gov registration is required. Two outcomes follow: (1) “Registration Required” – UFCT-gov creates a basic shell registration for the principal investigator (PI) to review and complete. (2) “Registration Not Required” – If registration is not required (for example, for ICMJE publication or voluntary registration), the PI is responsible for completing the registration process.

ClinicalTrials.gov Registration Process

  • Submit your study to the Institutional Review Board (IRB).
  • UFCT-gov conducts an ancillary review upon IRB submission to determine whether ClinicalTrials.gov registration is required.
  • If registration is required:
    • UFCT-gov creates a basic shell record in ClinicalTrials.gov.
    • The principal investigator (PI) reviews and completes the registration.
  • If registration is not required:
    • The PI is responsible for completing the registration process if pursuing publication (e.g., ICMJE) or voluntary registration.

Helpful Resources

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.

Download PDF
CT.gov checklist

Helpful tips

Tips for Working in CT.gov PRS Beta

Note: For records already existing on 8/28/2024, investigators can navigate back to the familiar format to continue working in CT.gov

Visit Site
Tips for working in CT.gov

Leaving UF?

When an Investigator leaves UF, one of the things that is often overlooked is the ClinicalTrials.gov record.  

For studies where the Investigator is the PI of a study listed on ClinicalTrials.gov and is leaving UF, there are two options depending on whether the study will remain at UF or transfer with the PI:

  1. Research stays at UF and continues under a new PI
    • revision to the study to change PI must be approved by the UF IRB
    • ClinicalTrials.gov study record updated to reflect new PI/staff
  1. Research transfers to new institution with the same PI
    • UF DSP (and any other UF dept that would need to ok transfer of funded study to another institution) documentation of agreement to transfer
    • Documentation of acceptance of transfer receiving institution
    • the PI should email UFCT-gov@ufl.edu to initiate the record transfer at least 30 days prior to leaving UF