Registering a Study on ClinicalTrials.gov

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 external site (opens in a new window) .

The current practice at UCSF is to create and maintain a study record under the ClinicalTrials.gov Protocol Registration and Results System (PRS) external site (opens in a new window) 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.

The ClinicalTrials.gov PRS Registration Guided Tutorial external site (opens in a new window) should be completed before starting a new study record and offers step-by-step instructions and guidance for completing the record modules.
The UCSF Creating a Study Record external site (opens in a new window) guide provides institutional specific guidance for UCSF.
The PRS Quality Control Criteria external site (opens in a new window) document includes examples of acceptable and unacceptable record content, including outcome measures.
The PRS User's Guide external site (opens in a new window) and Data Element Definitions external site (opens in a new window) documents provide additional guidance and definitions.

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.

The ClinicalTrials.gov Regulatory Support Team assists UCSF researchers with ClinicalTrials.gov compliance, regulations, and institutional policy.
Contact CT.gov@ucsf.edu external site (opens in a new window) for ClinicalTrials.gov help at UCSF, including Study Registration assistance.
Contact ClinicalTrials.gov PRS at register@clinicaltrials.gov external site (opens in a new window)