ClinicalTrials.gov Requirements

September 29, 2025

ClinicalTrials.gov Requirements

Investigators may be required and/or plan to register their human research clinical trial with the ClinicalTrials.gov website. When registering on ClinicalTrials.gov, information must be submitted electronically in the format specified by the applicable requirement or by the website. Individuals who register their studies at ClinicalTrials.gov are responsible for complying with all requirements regarding registration and/or results reporting.

ClinicalTrials.gov Protocol Registration and Results System (PRS) Account

ClinicalTrials.gov PRS accounts for MSU individuals are provided by the MSU Human Research Protection Program (HRPP) Compliance office. Accounts are only provided to MSU individuals who have a clinical trial with human subjects that has been submitted in the MSU IRB Online System.

While individuals other than MSU faculty may receive a ClinicalTrial.gov PRS account, only MSU faculty may be designated as the Responsible Party.

New Process

MSU Principal Investigators responsible for registering a clinical trial must complete a form, HRP-583: PI Acknowledgement for ClinicalTrials.gov. The MSU HRPP Compliance office will work with the MSU PI to obtain a completed form when it is required.

Learn more in the HRPP Manual Sections:

• 7-9, ClinicalTrials.gov Requirements
• 7-9-A, ClinicalTrials.gov Requirements: General Requirements under 42 CFR 11
• 7-9-B, ClinicalTrials.gov Requirements: Applicable Clinical Trials under 42 CFR 11
• 7-9-C, ClinicalTrials.gov Requirements: Required Updates under 42 CFR 11
• 7-9-D, ClinicalTrials.gov Requirements: Voluntary Registration and/or Results Reporting under 42 CFR 11
• 7-9-E, ClinicalTrials.gov Requirements: National Institutes of Health