ClinicalTrials.gov Website

What is ClinicalTrials.gov?

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to clinical study information on a wide range of diseases and conditions.

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the website before they begin enrolling participants, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends.  Each entry may include the following:

  • Trial Protocol                                     
  • Purpose
  • Recruitment Status
  • Enrollment Criteria
  • Trial Location
  • Contact Information
  • Study Summary Results
  • Outcome Measures
  • Adverse Even Information

 

Why Register:

ClinicalTrials.gov Decision Chart

Required by law!

Section 801 of the Food and Drug Administration (FDA) Amendments Act mandates the registration with ClinicalTrials.gov of certain clinical trials of drugs (including biologics) and medical devices subject to FDA regulations for any disease or condition. More information, please review: http://clinicaltrials.gov/ct2/manage-recs/fdaaa.


Who is responsible for registering trials on ClinicalTrials.gov?

NIH Identification of Responsible Party

 

What trials must be registered on ClinicalTrials.gov?

NIH Identifying Applicable Clinical Trial(s)

Required for Journal Publications:

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. 

http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

 

For more information regarding ClinicalTrials.gov, please review the following:

 

What trials must be registered on ClinicalTrials.gov?

How do investigators know if their trial should be registered on ClinicalTrials.gov?

Who is responsible for registering trials on ClinicalTrials.gov?

When to register on ClinicalTrials.gov? 

When to report results on ClinicalTrials.gov?

Are there penalties if I fail to register or submit results on ClinicalTrials.gov?

How does the FDA Amendments Act of 2007 affect University of Utah Investigators?

Guidance for Results and Adverse Events Reporting

Steps for registering your clinical trial(s) at University of Utah.

Assistance with ClinicalTrials.gov Account Management.

Certification of Compliance

Recent Updates and FAQ

Related Links


Contact:

ClinicalTrials.gov Inquiries at the University of Utah

University of Utah PRS Administrator for ClinicalTrials.gov

Kristin Kolsch, FDA Clinical Research Compliance Officer

kristin.kolsch@hsc.utah.edu

(801)587-0835

General Inquiries for ClinicalTrials.gov

Reporting Assistance

Bernie LaSalle, Operations Director,

CCTS Biomedical Research Informatics Service Core*

bernie.lasalle@hsc.utah.edu

801-213-4093

 

*Costs vary depending on the type of support required and the availability of data for the report summary tables.  Please contact Bernie LaSalle to discuss your support request.

Clinicaltrials.gov Contact
Email: register@clinicaltrials.gov

If you encounter any broken links on this page, please let us know by email: Kristin.kolsch@hsc.utah.edu