Registering a Study on ClinicalTrials.gov

Questions? Contact Clinical Trials Regulatory Support

Overview

All Clinical Trials (all phases and intervention types) must be registered before enrolling the first subject according to the UCSF Clinical Trials Registration & Reporting Policy.

Protocol Registration and Results System (PRS) User Accounts

The current practice at UCSF is to create and maintain a study record under the ClinicalTrials.gov Protocol Registration and Results System (PRS) user account of the Principal Investigator on the IRB application.

  • This means that PRS accounts will be created for PIs, and PIs may share PRS login credentials with staff and delegate the responsibility of creating and maintaining study records to research support staff.
    • PRS account passwords should be unique if shared.
  • When/if there are personnel changes, the PI will remain the record owner.

Contact [email protected] for assistance with creating a user account. 

Resources for Registering a Study

Who is the "Responsible Party"?

If the UCSF investigator holds an IND or IDE: the IND or IDE holder must be listed as the Responsible Party as the Sponsor-Investigator.

If there is no IND or IDE: UCSF must be listed as the Responsible Party as the Sponsor. 

 

Support