ClinicalTrials.gov Regulatory Support

The ClinicalTrials.gov Regulatory Support Team within the Office of Ethics and Compliance (OEC) provides free consultations and assistance to UCSF clinical researchers with ClinicalTrials.gov compliance requirements including:

  • Study record registration
  • Resolving ClinicalTrials.gov Protocol Registration and Reporting System (PRS) review comments
  • Record maintenance
  • Addressing results reporting issues

ClinicalTrials.gov Regulatory Support Partners

Compliance with ClinicalTrials.gov regulations and institutional policy is a team effort across many different stakeholders. A chart outlining roles and responsibilities of the various stakeholders is provided below.

Roles and Responsibilities for Compliance with ClinicalTrials.gov Protocol Registration and Reporting Requirements and Related Institutional Policy.

Establishing user accounts for Principal Investigators (PIs)

To establish user accounts for ClinicalTrials.gov, please email the ClincialTrials.gov Regulatory Support Team at [email protected].

Resources

An archive of our ClinicalTrials.gov Regulatory Support Newsletter, more information, and resources can be found on the UCSF Clinical Research Resource HUB ClinicalTrials.gov page.

Key Contacts