ClinicalTrials.gov

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

https://prsinfo.clinicaltrials.gov/prs-users-guide.html#intro

Video overview of Protocol Registration Information for Clinical Researchers

Protocol Registration Information