CORE--CLINICAL PROTOCOLS AND DATA MANAGEMENT

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，对中心的所有临床试验活动进行集中管理和监督。共享资源提供了一系列的管理和质量控制功能，是必不可少的进行临床试验研究在夏威夷的分散的社区实践设置。它包括所有癌症方案的中心位置、方案特定数据的集中数据库、供中心研究者使用的当前活动方案的更新列表以及方案的状态报告。 在夏威夷的多个社区办公室和医疗中心激活和监测协议的组织，涉及多个机构审查委员会（IRB）。质量控制职能包括：通过数据和安全性监测计划确保受试者安全和符合联邦要求，通过培训研究护士、CRA、临床试验助理和社区办公室、诊所和从事夏威夷癌症临床试验企业的医院工作人员确保工作人员的能力，并通过重点外展活动确保招募服务不足的少数民族。

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.