In This Section

A Comprehensive Cancer Center Designated by the National Cancer Institute

Cancer Clinical Trials Office

Scientific Director: Marcy A. List, PhD
Technical Director: Sumati Murli, PhD

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 Biostatistics Core Facility, the Protocol Review and Monitoring System (PRMS), and the UCCCC Informatics Group.

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)
  • Submit Letters of Intent (LOIs) and coordinate NCI review and approval of NCI-sponsored Phase I and Phase II studies
  • Prepare IRB forms, PI-initiated IND applications, FDA annual reports, amendments, and communications
  • Report and track serious adverse events and IND safety reports; coordinate review of external safety reports

Affiliate Institution Coordination and Oversight
Provide infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCCC:

  • Serve as the primary regulatory point of contact between the UCCCC 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
  • Generate reports for DSM conferences and file required reports to the NCI or cooperative groups
  • Coordinate Site Initiation Visits

Protocol Tracking, Management

  • Enter protocol-specific data into a centralized database (Velos eResearch)
  • Provide web-based direct access (e.g., in clinics) to current protocol documents (e.g., consent forms)
  • Generate serious adverse events, and other status reports

Quality Control

  • Provide required training to nurses, data managers, faculty, fellows and regulatory managers across departments
  • Support continuing education
  • Oversee designated data and safety monitoring activities [e.g., tracking unanticipated problems (UPs)]
  • Coordinate the audit program
  • Develop and implement associated Standard Operating Procedures (SOPs) (e.g., Serious Adverse Event reporting, audits)

Events