What You Need to Know About ClinicalTrials.gov Registration

In order to register a clinical trial in the National Library of Medicine’s (NLM) ClinicalTrials.gov registry, you or your designee will need to have a Protocol Registration System (PRS) individual or organization account. This account will allow you to create and update your clinical trials records as necessary. More details are available on the PRS website.

Guidance available from NIH on roles and responsibilities regarding ClinicalTrials.gov

From the NIH Office of Extramural Research:

• What NIH Grantees Need to Know About ClinicalTrials.gov and FDAAA
• ClinicalTrials.gov and FDAAA: FAQs for NIH Grantees

Additional guidance from ClinicalTrials.gov on creating and updating your trial record

• Registering Clinical Trials with ClinicalTrials.gov
• PRS and U.S. Public Law 110-85
• Data Element Definitions
• “Basic Results” Data Element Definitions
• Delayed Submission of Results
• Adverse Event Reporting