Registration and Submission of Clinical Trials Data

癌症临床试验办公室（CCTO）为芝加哥大学癌症研究中心（UCCRC）的临床试验活动提供监督和质量控制，通过提供政策和程序、监督员工、审计和跟踪这些活动的集中数据库来集中监管和报告功能。CCTO的总体目标是提供基础设施，以支持跨部门成功的临床研究。该办公室与生物统计核心设施，方案审查和监测系统（PRMS）以及UCCRC的信息学亚单位进行互动。

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 through the provision of policies and procedures, supervision of staff, auditing, and a centralized database for tracking of these activities. The overall objective of the CCTO is to provide the infrastructure to support successful clinical research across departments. The office interacts with the Biostatistical Core facility, the Protocol Review and Monitoring System (PRMS), and the informatics subunit of the UCCRC. The services provided 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 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 (SAM) of the UCCRC, and IND submissions. 2) Affiliate Institution Coordination and Oversight: 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. 3) Protocol Tracking, Management: 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. 4) Quality Control: 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., SAE tracking, coordination of High-Risk Protocol Conference HRPC), coordination of the audit program, and development and implementation of Standard Operating Procedures (SOPs).