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 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. The services provided by the CCTO can be broadly categorized under the following key functions:

  • Regulatory Affairs: The CCTO provides centralized regulatory management for the conduct of all cancer clinical trials at the University of Chicago regardless of sponsor, department, or type of study. These services include 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:  The CCTO provides infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCRC, including 8 CALGB affiliate institutions, 15 Phase II NCI contract affiliate institutions, and over 15 additional ad hoc affiliates participating in selected studies.  The CCTO coordinates all study-related communications, serves as the point of patient registration for some programs, and reviews operations to ensure compliance with federal regulations. 
  • Protocol Tracking, Management:  The CCTO provides a centralized location and database (Velos eResearch) for tracking protocol-specific data, including study teams, protocol status, and patient registration; provides 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: The CCTO provides training of regulatory managers across departments, continuing education, support to nurses, data managers, faculty and fellows in the use of Velos eResearch, oversight of designated data and safety monitoring activities (e.g., severe adverse event tracking, coordination of High-Risk Protocol Conference HRPC), coordination of the audit program, and development and implementation of Standard Operating Procedures.