Cancer Clinical Trials Office
The Cancer Clinical Trials Office (CCTO) provides oversight and quality control for cancer clinical trials at the University of Chicago Medicine through centralized regulatory management, reporting, staff supervision and training, auditing, and event tracking. The overall objective of the CCTO is to provide the infrastructure to support successful clinical research across departments. The CCTO interacts with the investigator, clinical research staff, Biostatistics Core Facility, the Protocol Review and Monitoring System (PRMS), and the Comprehensive Cancer Center Informatics Group.
Scientific Director: Steven Chmura, MD, PhD
Technical Director: Amanda Spratt, BS, CCRP
Services
Regulatory Affairs
Provide centralized regulatory management for the conduct of all adult cancer clinical trials at UChicago regardless of sponsor, department, or type of study:
- Complete required forms and submissions to the Clinical Trials Review Committee (CTRC), the Institutional Review Board (IRB), and other required committees (e.g., Institutional Biosafety Committee)
- Prepare principal investigator-initiated investigational new drug (IND) applications, FDA annual reports, amendments, and communications
- Report and track serious adverse events, and ensure discussion and review at the relevant Data and Safety Monitoring Conference with appropriate follow-up for unanticipated problems
Affiliate Institution Coordination and Oversight
Provide infrastructure for the participation of affiliate institutions enrolling patients on trials at the Comprehensive Cancer Center:
- Serve as the primary regulatory point of contact between Comprehensive Cancer Center investigators and outside institutions or cooperative groups
- Manage affiliate or cooperative group communications document distribution and response to queries
- Collect and track affiliate site initial and continuing IRB approvals and all other regulatory documents
Protocol Tracking, Management
- Enter protocol-specific data into a centralized database (Velos eResearch) to enable tracking and generate status reports
- Provide web-based direct access (e.g., in clinics) to current protocol documents (e.g., consent forms)
Quality Control
- Provide required training to nurses, data managers, faculty, fellows, clinical research staff, and regulatory managers across departments
- Oversee designated data and safety monitoring activities [e.g., tracking unanticipated problems (UPs)]
- Coordinate the audit program
- Develop and implement Standard Operating Procedures (SOPs) (e.g., Serious Adverse Event reporting, audits)
Effective Date: 7/1/23 - 6/30/2024
