Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov

All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications submitted on or after 1/18/2017 . This website provides resources for understanding and complying with this NIH policy and the federal regulations in Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) as implemented by 42 CFR Part 11 (Final Rule).

Decision Tree

Steps for NIH Applicants & Grantees

This decision tree guides you through specific actions and checkpoints related to the NIH policy and federal regulations on registering and submitting results information to Clinicaltrials.gov.

Notebook labeled Policy

Policy and Regulations on Clinicaltrials.gov Registration and Reporting

Learn how NIH’s Clinicaltrials.gov registration and reporting policy relates to the federal regulations.