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).

CCTO提供了支持大学所有部门成功癌症临床研究的基础设施，并支持U芝加哥的癌症临床试验。它通过实施政策和程序来提供监督和质量控制，通过集中监管和报告职能，对员工的监督，审计以及通过集中式数据库跟踪这些活动。我们是全国仅有的四个机构之一，是NCI 1期合作协议和11期临床试验合同的主要机构，是多个合作团体的成员，并且在第11阶段计划和CALGB/Alliance方面拥有良好的分支机构机构网络。平均而言，我们每年进行300-350次治疗试验，并进行100-150次开放的非治疗试验。该办公室与生物统计学核心设施，协议审查和监控系统（PRMS）和UCCCC信息学组进行互动。 CCTO提供的服务可以广泛 根据以下关键功能进行分类： 1。监管事务：集中监管管理（例如，临床试验审查委员会 （CTRC） /IRB提交； INDS）对于所有Uchicago癌症临床试验，无论赞助商如何 部门，学习类型或阶段。小儿肿瘤学试验使用卫星办公室进行操作，并遵循所有CCTO政策和程序。 2。协议跟踪和管理：集中位置和数据库（velos eresearch） 跟踪特定于协议的数据和患者注册；提供基于Web的直接访问（例如 诊所）到当前的协议文件（例如同意书）；和报告生成。 3。会员机构协调和监督：参与会员的基础设施 在UCCCC参加试验的机构，包括7个CALGB/Alliance分支机构机构，10期NCI合同分支机构机构，以及超过40多个额外的临时分支机构，参加了该疾病计划中的选定研究。 4。质量控制：临床研究和Velos Eresearch的培训；监督数据和安全性 监视活动；审计计划的协调；以及开发和实施 标准操作程序（SOP）。