ClinicalTrials.gov Resources

ClinicalTrials.gov allows patients, their family members, healthcare professionals, researchers, and the public access to information on clinical studies.

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the research study.

U OF U CLINICALTRIALS.GOV GUIDELINES

When conducting an Applicable Clinical Trial (ACT) per U.S federal regulations (42 CFR Part 11)

This includes:

Controlled clinical trials of FDA-regulated drugs or biologics (Phases II - IV); and
Controlled clinical trials and pediatric post-market surveillance of FDA-regulated devices (other than small feasibility studies).
See the ClinicalTrials.gov "Applicable Clinical Trial (ACT)" checklist (https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf )to determine if registration of a study is required per federal regulations.

When conducting a clinical trial funded by the National Institutes of Health (NIH) per NIH policy

If the answer is “yes” to all four of the following questions, then the research study would be considered a clinical trial according to the NIH definition:

Does the study involve human participants?
Are the participants prospectively assigned to an intervention?
Is the study designed to evaluate the effect of the intervention on the participants?
Is the effect being evaluated a health-related biomedical or behavioral outcome?

See NIH Definition of Clinical Trial Case Studies for additional guidance
in determining if a research study is an NIH defined clinical trial.

For publication in a journal that follows the International Committee of Medical Journal Editors' (ICMJE) policy

which requires registration of clinical trials in a public trials registry as a condition of consideration for publication.

Topics	Resources
Account, Protocol Registration and Record Maintenance	request a user account How to Register Your Study Protocol Registration Data Element Definitions for Interventional and Observational Studies How to Edit Your Study Record
Result Reporting	How to Submit Results Results Data Element Definitions for Interventional and Observational Studies
National Institutes of Health (NIH)	NIH Policy on Dissemination of NIH Funded Clinical Trial Information NIH Data Management and Sharing Policy NIH Application Dissemination Plan Template Language
International Committee of Medical Journal Editors (ICMJE)	ICMJE policy ICJME Guidelines and Data Sharing
ICF Language, ICF Upload – Common Rule	ICF Language, ICF Upload – Common Rule
Education and Training	RED 743 \| Introduction to ClinicalTrials.gov
Links and Supplementary Resources	ClinicalTrials.gov FAQ Timeline Table Regulatory Oversight Table
PI Off Boarding	Principal Investigator Off-Boarding (Resignation/Termination) Policy
Civil Money Penalties	FDA Guidance: Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
University of Utah Clinical Trials.Gov Contacts	Department Contact List

Topics

Resources

Account, Protocol Registration and Record Maintenance

request a user account

Result Reporting

National Institutes of Health (NIH)

International Committee of Medical Journal Editors (ICMJE)

ICF Language, ICF Upload – Common Rule