ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
Protocol Registration is required to make study information publicly available to:
- Facilitate enrollment in clinical trials
- Allow tracking of study progress
- Provide dissemination of study findings
- Ensure access to peer-reviewed journals for publication of research outcomes
Protocol Registration is required by:
- Food and Drug Administration Amendments Act 2007 (FDAAA)
- National Institutes of Health (NIH)
- International Committee of Medical Journal Editors (ICMJE)
- Center for Medicare and Medicaid (CMS)
International Committee of Medical Journal Editors (ICMJE) requires protocol registration of interventional clinical studies to include studies of any intervention type, phase, or geographic location BEFORE enrollment of first subject.
Determine if your study is an Applicable Clinical Trial that should be registered.
ClinicalTrials.gov Protocol Registration User’s Guide
Video overview of Protocol Registration Information for Clinical Researchers
- If you need to register a study in ClinicalTrial.gov, send the following information to firstname.lastname@example.org
- Name and title with degrees
- UT NetID
- You will receive instructions by email from the UTHSC ClinicalTrials.gov administrator for registering your study.