ClinicalTrials.gov
ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.
Protocol registration is required make study information publicly available to facilitate enrollment in clinical trials, allow tracking of study progress, disseminate study findings, and 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.
UTHSC procedures for ClinicalTrials.gov registration
If you need to register a study in ClinicalTrials.gov, send the following information to Ansley Parker, CTU Research Assistant:
- Name and title with degrees
- UT NetID
You will receive instructions by email from the UTHSC ClinicalTrials.gov administrator for registering your study.