ClinicalTrials.gov Regulatory Support

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

  • Creation and maintenance of ClinicalTrials.gov Protocol Registration and Reporting System (PRS) user accounts
  • Assistance with study record registration, maintenance, and results reporting
  • Support for ClinicalTrials.gov PRS quality control (QC) review comments
  • Assistance with FDA and NIH clinical trial registration and reporting compliance

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.

ClinicalTrials.gov User Accounts for Principal Investigators (PIs)

For assistance with user accounts for the ClinicalTrials.gov PRS, please email the ClincialTrials.gov Regulatory Support Team at [email protected].

Resources

Detailed resources, announcements, and more information about ClinicalTrials.gov for UCSF researchers can be found on our ClinicalTrials.gov resources site.

Key Contacts