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、对员工的监督、审计和用于跟踪这些活动的中央数据库来集中监管和报告职能。CCTO的总体目标是提供基础设施，以支持跨部门的成功临床研究。该办公室与生物统计核心设施、议定书审查和监测系统(PRMS)以及UCCRC的信息学分部进行互动。 CCTO提供的服务大致可分为以下主要职能： 1)监管事务：对芝加哥大学所有癌症临床试验的进行进行集中监管管理，无论赞助商、部门或研究类型。这些服务包括填写所需的表格并提交给临床试验审查委员会(CTRC)、机构审查委员会(IRB)和其他所需的委员会(例如机构生物安全委员会)；每年向IRB和UCCRC的科学和应计监测委员会(SAM)续签；以及IND提交。 2)附属机构协调和监督：附属机构在UCCRC招募患者参与试验的基础设施，包括8个CALGB附属机构，15个NCI第二阶段合同附属机构，以及参与选定研究的另外15个特别附属机构。CCTO协调所有与研究相关的沟通，充当某些项目的患者登记点，并审查操作以确保符合联邦法规。 3)方案跟踪和管理：用于跟踪方案特定数据的集中位置和数据库(VELOS EResearch)，包括研究团队、方案状态和患者登记；提供对当前同意书、方案和研究手册的基于Web的直接访问(例如，在诊所)；以及关于临床数据和研究状态信息的报告生成。 4)质量控制：培训各部门的监管经理，继续教育，支持护士、数据经理、教员和研究员使用VELOS电子研究，监督指定数据和安全监测活动(例如，SAE跟踪、协调高风险议定书会议HRPC)，协调审计计划，以及制定和实施标准操作程序(SOP)。

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).