CANCER CLINICAL TRIALS OFFICE

CCTO提供基础设施，支持大学内所有院系的成功癌症临床研究，并支持芝加哥大学的癌症临床试验。它通过执行政策和程序提供监督和质量控制，通过中央数据库集中监管和报告职能、监督工作人员、审计和跟踪这些活动。我们是全国仅有的四家同时担任NCI第1阶段合作协议和第11阶段临床试验合同牵头机构的机构之一，是多个合作团体的成员，并拥有良好的第11阶段计划和CALGB/联盟附属机构网络。平均而言，我们每年有300-350个治疗试验开放，另外100-150个开放的非治疗试验。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UCCCC信息学小组进行互动。CCTO提供的服务可以广泛地 归类于以下主要职能： 1.监管事务：集中监管管理(如临床试验评审委员会 (CTRC)/IRB提交；INDS)所有芝加哥大学癌症临床试验，无论赞助商， 部门、研究类型或阶段。儿科肿瘤学试验使用卫星办公室进行操作，并遵循CCTO的所有政策和程序。 2.协议跟踪和管理：集中定位和数据库(Velos EResearch) 跟踪特定于协议的数据和患者登记；提供基于Web的直接访问(例如，在 到当前的协议文件(例如，同意书)；以及报告的生成。 3.附属机构协调和监督：附属机构参与的基础设施 在UCCCC招募患者参加试验的机构，包括7家CALGB/联盟附属机构、10家11期NCI合同附属机构，以及40多家参与疾病计划内选定研究的特别附属机构。 4.质量控制：临床研究和Velos eResearch培训；数据和安全监督 监测活动；协调审计方案；制定和实施 标准操作程序(SOP)。

The CCTO provides the infrastructure to support successful cancer clinical research across all departments within the University and supports cancer clinical trials at the U Chicago. It provides oversight and quality control through the implementation of policies and procedures, by centralizing regulatory and reporting functions, supervision of staff, auditing, and tracking of these activities with a centralized database. We are one of only four institutions nationally to be the lead institution for both an NCI Phase 1 cooperative agreement and a Phase 11 Clinical Trials Contract, are members of multiple cooperative groups, and have well established networks of affiliate institutions for both the Phase 11 program and CALGB/Alliance. On average, we have 300-350 therapeutic trials open to accrual per year, and an additional 100-150 open nontherapeutic trials. The office interacts with the Biostatistics Core Facility, the Protocol Review and Monitoring System (PRMS), and the UCCCC Informatics Group. Services provided by the CCTO can be broadly categorized under the following key functions: 1. Regulatory Affairs: Centralized regulatory management (e.g.. Clinical Trials Review Committee (CTRC) /IRB submission; INDs) for all UChicago cancer clinical trials regardless of sponsor, department, study type, or phase. Pediatric Oncology trials operate using a Satellite office, and follow all CCTO policies and procedures. 2. Protocol Tracking and Management: Centralized location and database (Velos eResearch) for tracking protocol-specific data and patient registration; provides web-based direct access (e.g., in clinics) to current protocol documents (e.g., consent forms); and report generation. 3. Affiliate Institution Coordination and Oversight: Infrastructure for the participation of affiliate institutions enrolling patients on trials at the UCCCC, including 7 CALGB/Alliance affiliate institutions,10 Phase 11 NCI contract affiliate institutions, and over 40 additional ad hoc affiliates participating in selected studies within the Disease Programs. 4. Quality Control: Training in clinical research and Velos eResearch; oversight of data and safety monitoring activities; coordination of the audit program; and development and implementation of Standard Operating Procedures (SOPs).