ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted in the United States and around the world. Clinical trials are registered with ClinicalTrials.gov via a web-based data entry system called the Protocol Registration System. Study registration and results reporting of “applicable clinical trials” is mandated by Public Law 110-85, also known as the Food and Drug Administration Amendments Act (FDAAA) of 2007. For a definition of “applicable clinical trials” please visit the NIH website.
The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication.
Protocol Record Access
Registration and Results Reporting
- PIs are required to register their trials no later than 21 days after enrolling the first subject and to review and verify the clinical trial records at least once every 6 months, but no less frequently than every 12 months. Additional requirements exist and may require more frequent reporting if, for example, there are recruitment changes, adverse events and/or if a trial enrolls its final participant. Study results must be posted no later than 12 months from the completion date. This date is called the “Primary Completion Date” and is entered at the time of the initial registration.
- Please note:There are stringent rules governing clinicaltrials.gov registration and results reporting that may involve fines for non-compliance.