The Clinical Trials Office (CTO) routinely monitors all active studies to ensure that clinical trials adhere to research protocols, applicable Federal and State regulations, ICH GCP guidelines, and all University policies and procedures.
All studies are monitored for the following:
- Study binders: essential document review
- Subject charts: source data verification (SDV)
- Protocol compliance and deviations
- Informed consent
- Adherence to GCP
- Adherence to regulations, guidelines, and SOPs
- IRB applications, approval notices, reports, correspondence
- Conflict of interest/financial disclosure
- Safety reporting
- Pharmacy and investigational product (IP) accountability
- Laboratory procedures
- Training records
- Site support
- Adverse events (AE)/safety review
- Site performance assessment
- Study progress against milestones
Leadership
J. Michael Dean, MD, MBA
Associate Dean for Clinical Research
Professor
Vice Chairman for Research
Department of Pediatrics
Director, Clinical Trials Office
Chief, Division of Pediatric Critical Care
University of Utah School of Medicine
Contact Us
Contact Us:
Phone: 801-587-7514
Email: ClinicalTrialsOffice@hsc.utah.edu