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.
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 |
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.
How does it work?
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.
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
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:
- 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
- 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