CORE--CLINICAL PROTOCOLS AND DATA MANAGEMENT

核心——临床方案和数据管理

• 批准号: 7110860
• 负责人: BRIAN F ISSELL
• 金额: $ 5.09万
• 依托单位: UNIVERSITY OF HAWAII AT MANOA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7110860
• 关键词: biomedical facility; clinical trials; data management; experimental designs; neoplasm /cancer

The Clinical Protocol and Data Management Shared Resource (CPDM) is a component of the Center's Clinical Trials Unit that provides central management and oversight of all clinical trials activities of the Center. The Shared Resource provides a range of management and quality control functions that are essential for conducting clinical trials research in Hawaii's decentralized community practice setting. It includes a central location for all cancer protocols, a centralized database of protocol-specific data, an updated list of currently active protocols for the use of Center investigators, and status reports of protocols, It provides a centralized organization for activating and monitoring protocols throughout Hawaii's multiple community offices and medical centers involving several Institutional Review Boards (IRBs). Quality control functions include: insuring subject safety and compliance with federal requirements through the Data and Safety Monitoring plan, insuring staff competency through training for research nurses, CRAs, clinical trials assistants and community office, clinic, and hospital staff engaged in Hawaii's cancer clinical trials enterprise, and insuring recruitment of underserved minorities through focused outreach activities.

临床方案和数据管理共享资源（CPDM）是中心临床试验部门的一个组成部分，为中心的所有临床试验活动提供中央管理和监督。共享资源提供了一系列管理和质量控制功能，这些功能对于在夏威夷分散的社区实践环境中进行临床试验研究至关重要。它包括所有癌症协议的中心位置，特定协议数据的集中数据库，中心调查员使用的当前有效协议的更新列表，以及协议的状态报告，它提供了一个集中的