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 and contract proposals submitted on or after January 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).
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.
Policy and Regulations on Clinicaltrials.gov Registration and Reporting
Learn how NIH’s Clinicaltrials.gov registration and reporting policy relates to the federal regulations.