Wayne State University

Important ClinicalTrials.gov Requirements

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The database lists over 250,000 studies with locations in all 50 states and 200 countries.

Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires Responsible Parties to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices.

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."

To learn more about how to register a clinical study, visit http://research.wayne.edu/irb/clinicaltrials.php.