The Cancer Clinical Trials Office (CCTO) provides oversight and quality control for University of ChicagoCancer Research Center's (UCCRC) clinical trials activity by centralizing regulatory and reporting functionsthrough the provision of policies and procedures, supervision of staff, auditing, and a centralized databasefor tracking of these activities. The overall objective of the CCTO is to provide the infrastructure to supportsuccessful clinical research across departments. The office interacts with the Biostatistical Core facility, theProtocol Review and Monitoring System (PRMS), and the informatics subunit of the UCCRC. The servicesprovided by the CCTO can be broadly categorized under the following key functions:1) Regulatory Affairs: Centralized regulatory management for the conduct of all cancer clinical trials atthe University of Chicago regardless of sponsor, department, or type of study. These services includecompletion of required forms and submission to the Clinical Trials Review Committee (CTRC), theInstitutional Review Board (IRB), and other required committees (e.g., Institutional BiosafetyCommittee); annual renewals to the IRB and the Scientific and Accrual Monitoring Committee (SAM)of the UCCRC, and IND submissions.2) Affiliate Institution Coordination and Oversight: Infrastructure for the participation of affiliateinstitutions enrolling patients on trials at the UCCRC, including 8 CALGB affiliate institutions, 15Phase II NCI contract affiliate institutions, and over 15 additional ad hoc affiliates participating inselected studies. The CCTO coordinates all study-related communications, serves as the point ofpatient registration for some programs, and reviews operations to ensure compliance with federalregulations.3) Protocol Tracking, Management: Centralized location and database (Velos eResearch) for trackingprotocol-specific data, including study teams, protocol status, and patient registration; provides webbaseddirect access (e.g., in clinics) to current consent forms, protocols, and investigationalbrochures; and report generation with respect to both clinical data and study status information.4) Quality Control: Training of regulatory managers across departments, continuing education, supportto nurses, data managers, faculty and fellows in the use of Velos eResearch, oversight of designateddata and safety monitoring activities (e.g., SAE tracking, coordination of High-Risk ProtocolConference HRPC), coordination of the audit program, and development and implementation ofStandard Operating Procedures (SOPs).
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