Scientific Director: Marcy A. List, PhD
Technical Director: Consuelo Skosey, RN, CCRP
Website: cancer.uchicago.edu
The Cancer Clinical Trials Office (CCTO) provides oversight and quality control for The University of Chicago Comprehensive Cancer Center's (UCCCC) clinical trials activity by centralizing regulatory and reporting functions. The overall objective of the CCTO is to provide the infrastructure to support successful clinical research across departments.
Services
Regulatory Affairs:
- Provide centralized regulatory management for the conduct of all cancer clinical trials at UChicago regardless of sponsor, department, or type of study, including the completion of required forms and submission to the Clinical Trials Review Committee (CTRC), the Institutional Review Board (IRB), and other required committees (e.g., Institutional Biosafety Committee)
- Prepare annual renewals to the IRB and the Scientific and Accrual Monitoring Committee of the UCCCC
- Provide support for investigational new drug submissions
Affiliate Institution Coordination and Oversight:
- Provide infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCCC [including Cancer and Leukemia Group B (CALGB) affiliate institutions, Phase II National Cancer Institute (NCI) contract affiliate institutions, and additional ad hoc affiliates participating in selected studies]
- Coordinate all study-related communications
- Serve as the point of patient registration for some programs
- Review operations to ensure compliance with federal regulations
Protocol Tracking, Management:
- Provide a centralized location and database (Velos eResearch) for tracking protocol-specific data (including study teams, protocol status, and patient registration)
- Provide web-based direct access (e.g., in clinics) to current consent forms, protocols, and investigational brochures
- Report generation with respect to both clinical data and study status information
Quality Control:
- Provide training of regulatory managers across departments
- Support continuing education
- Train nurses, data managers, faculty and fellows in the use of Velos eResearch
- Oversee designated data and safety monitoring activities [e.g., tracking Unanticipated Problems (UPs), coordination of High-Risk Protocol Conference]
- Coordinate the audit program
- Develop and implement Standard Operating Procedures and Suggested Practices
