Overview
The ClinicalTrials.gov Regulatory Support Team within the Office of Ethics and Compliance (OEC) provides support to UCSF clinical researchers with ClinicalTrials.gov submissions and reporting.
Contact CT.gov@ucsf.edu external site (opens in a new window) for assistance.
What we can assist with:
- 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.