An "Applicable Clinical Trial (ACT)," must be registered on the www.ClinicalTrials.gov website, when it meets the definition of an ACT according to the FDAAA 801 Requirements, or when required by other entities. To determine if your clinical trial must be registered use the Clinical Trials ACT Checklist or check the requirements of other entities such as the VA, CMS, WHO, PCORI, or ICMJE journals.
This Clinical Trials website provides more information on:
NOTE: Requirements may vary depending on the type of award and/or the sponsor.
Frequently Asked Questions: https://clinicaltrials.gov/ct2/manage-recs/faq#applicable
How to register a study: https://clinicaltrials.gov/ct2/manage-recs/how-register
How to edit a study record: https://clinicaltrials.gov/ct2/manage-recs/how-edit
How to submit results: https://clinicaltrials.gov/ct2/manage-recs/how-report
Sharon Levine-Sealy, Director of Pre-Award Operations
Elliot Feder, Director, Post-Award Research Administration
Kevin L. Nellis, MS, CIP, Executive Director
Human Research Protection & Quality Assurance
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Clinical Trials and Human Subject Protection at the U.S. Food and Drug Administration.
NIH Clinical Research Trials and You – National Institutes of Health (NIH)