Clinical Protocol and Data Management

临床方案和数据管理：摘要/摘要 本部分包括对HDfccc临床协议和数据管理(CPDM)功能的说明 以及数据和安全监控(DSM)功能。CPDM功能由临床研究提供 支持办公室(CRSO)，需求侧管理(DSM)由数据和安全监测委员会(DSMC)提供。这个 开展的所有癌症临床试验的开发、审查、实施、实施、监测和报告 在HDfccc中作为集中职能进行管理，需要CRSO和DSMC的协调 与礼宾审查和监测系统(PRMS)有关的活动。这种协调通过以下方式得到加强 组织临床研究基础设施，其中PRMS、DSMMC和CRSO的活动 保持独立，但由癌症中心临床研究监督委员会协调 (CCCROC；完整描述见主任概述和领导、规划和评估)。

Clinical Protocol and Data Management: Summary/Abstract This section includes descriptions of the HDFCCC Clinical Protocol and Data Management (CPDM) functions and Data and Safety Monitoring (DSM) functions. CPDM functions are provided by the Clinical Research Support Office (CRSO), and DSM is provided by the Data and Safety Monitoring Committee (DSMC). The development, review, implementation, conduct, monitoring, and reporting of all cancer clinical trials undertaken in the HDFCCC are managed as centralized functions, requiring the coordination of CRSO and DSMC activities with Protocol Review and Monitoring System (PRMS) activities. This coordination is enhanced by the organization of the clinical research infrastructure, in which the activities of the PRMS, DSMC, and the CRSO remain independent but are coordinated by the Cancer Center Clinical Research Oversight Committee (CCCROC; see Director's Overview and Leadership, Planning and Evaluation for full description).