Registration and Submission of Clinical Trials Data

临床试验数据的注册和提交

• 批准号: 8744809
• 负责人: MICHELLE M LE BEAU
• 金额: $ 7.64万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2018-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8744809
• 关键词: Biostatistics Core; Cancer Center Support Grant; Cancer and Leukemia Group B; Chicago; Clinic; Clinical Data; Clinical Research; Clinical Trials; Communication; Consent; Consent Forms; Continuing Education; Contracts; Core Facility; Data; Databases; Development; Enrollment; Ensure; Faculty; Generations; Informatics; Institution; Institutional Review Boards; Location; Malignant Neoplasms; Monitor; Nurses; Online Systems; Pamphlets; Patients; Phase; Policies; Procedures; Program Development; Program Reviews; Protocols documentation; Quality Control; Regulation; Regulatory Affairs; Reporting; Research Design; Research Infrastructure; Review Committee; Safety; Serious Adverse Event; Services; Supervision; System; Training; Universities; University of Chicago Cancer Research Center; high risk; institutional biosafety committee; operation; programs; symposium

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).

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、对工作人员的监督、审计以及用于跟踪这些活动的集中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来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 的信息学子单位进行互动。 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，无论申办者、部门或研究类型如何。这些服务包括填写所需表格并提交给临床试验审查委员会 (CTRC)、机构审查委员会 (IRB) 和其他所需委员会（例如机构生物安全委员会）；向 IRB 和 UCCRC 的科学与权责发生制监测委员会 (SAM) 进行年度更新，以及 IND 提交。 2) 附属机构协调和监督：附属机构参与在 UCCRC 招募患者参加试验的基础设施，包括 8 个 CALGB 附属机构、15 个 II 期 NCI 合同附属机构以及超过 15 个参与选定研究的其他临时附属机构。 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，并审查操作以确保遵守联邦法规。 3) 方案跟踪、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；提供基于网络的直接访问（例如在诊所）当前的同意书、协议和研究手册；以及有关临床数据和研究状态信息的报告生成。 4) 质量控制：跨部门监管管理人员的培训、继续教育、支持护士、数据管理人员、教师和研究员使用 Velos eResearch、监督指定数据和安全监测活动（例如 SAE 跟踪、协调高风险协议会议 HRPC）、协调审核计划以及制定和实施标准操作程序 (SOP)。