Registration and Submission of Clinical Trials Data

临床试验数据的注册和提交

基本信息

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
项目类别：
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

项目摘要

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）通过提供政策和程序，监督员工，审计以及集中的数据库来追踪监管和报告功能，为芝加哥癌症研究中心（UCCRC）的临床试验活动提供监督和质量控制。 CCTO的总体目标是提供基础设施，以支持各个部门成功的临床研究。该办公室与生物统计学核心设施，协议审查和监视系统（PRMS）和UCCRC的信息亚基相互作用。 CCTO提供的服务可以在以下关键功能下进行广泛分类： 1）监管事务：无论赞助商，系或研究类型如何，芝加哥大学进行所有癌症临床试验的集中监管管理。这些服务包括填写所需表格和提交临床试验审查委员会（CTRC），机构审查委员会（IRB）和其他必需委员会（例如机构生物安全委员会）； UCCRC的IRB和科学和应计监控委员会（SAM）和IND提交的年度续签。 2）会员机构的协调和监督：参与分支机构的基础设施，招募患者参加UCCRC试验的基础设施，包括8个CALGB分支机构机构，15个II NCI合同分支机构机构，以及超过15个其他Ad Hoc分支机构参与选定的研究。 CCTO协调所有与研究相关的通信，是某些计划的患者注册点，并审查操作以确保遵守联邦法规。 3）协议跟踪，管理：集中位置和数据库（VELOS ERESEARCH），用于跟踪协议特定数据，包括研究团队，协议状态和患者注册；提供基于Web的直接访问（例如，在诊所中），以提供当前同意书，协议和研究手册；并报告就临床数据和研究状态信息而产生的生成。 4）质量控制：跨部门的监管经理培训，继续教育，对使用Velos Eresearch的使用，对护士，数据经理，教师和研究员的支持，指定数据和安全监控活动的监督（例如，SAE跟踪，高风险协议HRPC协调），高风险协议HRPC），审核计划的协调，以及标准运营和制定过程（标准运营和实施）（SOPS的实施和实施）（SOPS）。