UCCRC Core Facilities: Cancer Clinical Trials Office

Scientific Director:  Marcy A. List, PhD

Technical Director:  Connie Skosey, RN, CCRP

Phone: 773-702-0819

Website:  http://uccrc.uchicago.edu/researchers/core_ccto.html

The Cancer Clinical Trials Office (CCTO) provides oversight and quality control for University of Chicago Cancer Research Center’s (UCCRC) 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 the University of Chicago 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);
    • Annual renewals to the IRB and the Scientific and Accrual Monitoring Committee of the UCCRC; and
    • Investigational new drug submissions.

Affiliate Institution Coordination and Oversight: 

    • Provide infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCRC ( including CALGB affiliate institutions, Phase II 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; and
    • 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; and
    • 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., severe adverse event tracking, coordination of High-Risk Protocol Conference HRPC);
  • Coordinate the audit program; and
  • Develop and implement Standard Operating Procedures.