CANCER CLINICAL TRIALS OFFICE

癌症临床试验办公室

• 批准号: 8486649
• 负责人: MICHELLE M LE BEAU
• 金额: $ 22.31万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8486649
• 关键词: Biostatistics Core; Cancer Center; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Cancer and Leukemia Group B; Chicago; Clinic; Clinical Research; Clinical Trials; Consent Forms; Contracts; Core Facility; Data; Databases; Development; Disease; Disorder by Site; Enrollment; Generations; Informatics; Institution; Institutional Review Boards; Instruction; Lead; Location; Malignant Neoplasms; Mission; Monitor; Online Systems; Patients; Pediatric Oncology; Phase; Policies; Procedures; Protocols documentation; Quality Control; Regulatory Affairs; Reporting; Research Design; Research Infrastructure; Research Personnel; Review Committee; Safety; Serious Adverse Event; Services; Supervision; System; Therapy Clinical Trials; Training; Translational Research; U-Series Cooperative Agreements; Universities; Vertebral column; member; novel therapeutic intervention; operation; programs; research and development; tool

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).

该CTO提供的基础设施，以支持在大学内的所有部门成功的癌症临床研究，并支持在U芝加哥癌症临床试验。它通过执行政策和程序、集中管理和报告职能、监督工作人员、审计以及用中央数据库跟踪这些活动，提供监督和质量控制。我们是全国仅有的四个机构之一，是NCI第1期合作协议和第11期临床试验合同的牵头机构，是多个合作团体的成员，并为第11期计划和CALGB/联盟建立了完善的附属机构网络。平均而言，我们每年有300-350项治疗性试验开放供招募，另外还有100-150项非治疗性试验开放供招募。该办公室与生物统计核心设施，方案审查和监测系统（PRMS）和UCCCC信息组进行互动。CTO提供的服务可以广泛地 按以下主要职能分类： 1.法规事务：集中的法规管理（例如：临床试验审查委员会 （CTRC）/IRB提交; IND），用于所有芝加哥大学癌症临床试验，无论申办者如何， 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，并遵循所有CTO政策和程序。 2.方案跟踪和管理：集中式位置和数据库（Velos eResearch）， 跟踪方案特定数据和患者登记;提供基于网络的直接访问（例如，在 诊所）到当前协议文档（例如，同意书）;和报告生成。 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个CALGB/联盟附属机构，10个11期NCI合同附属机构，以及40多个参与疾病计划内选定研究的额外特设附属机构。 4.质量控制：临床研究和Velos eResearch培训;数据和安全性监督 监督活动;协调审计方案;制定和执行 标准操作规程（SOP）。