Protocol Review and Monitoring

CCCWFU方案审查和监测系统（PRMS）为以下过程提供监督： 方案制定、方案审查和方案监测。这些程序支持内部监督 癌症临床试验的科学质量、方案优先级和进展评估。 方案制定由PRMS工作人员管理，他们协调工作流程以及 议定书审查委员会（PRC）以及议定书运作工作组（POW）。中国教师 成员评估研究的科学价值，以确保这些研究符合 CCCWFU。PRC检查方案与机构癌症患者人群的关系， 未满足的患者需求，并评估拟议方案的应计目标的可行性。委员会 按如下方式分配协议优先级：1）机构发起的协议，2）合作组， （3）产业研究。在这些组中，重点是针对CCCWFU的那些协议 方案目标。POW评估以下项目的操作和后勤可行性以及资源需求： 开发中的协议。战俘向中国报告其调查结果。 通过正式审查过程完成方案制定，并对方案进行同行审查评价 由PRC的成员。PRC还审查所有方案修正案。 方案监测发生在患者招募和分析的整个过程中。正在进行的安全性分析是 由临床研究监督委员会（CROC）完成，数据安全和监测 （见第12节）。此外，生物统计学共享资源和信息学小组 提供中期分析，以促进方案监测过程。

The CCCWFU Protocol Review and Monitoring System (PRMS) provides oversight for the processes of protocol development, protocol review, and protocol monitoring. These processes support internal oversight of the scientific quality, protocol prioritization and progress evaluation of cancer clinical trials. Protocol development in managed by PRMS staff who coordinate workflow as well as data requirements of the Protocol Review Committee (PRC) as well as the Protocol Operations Workgroup (POW). PRC faculty members evaluate the scientific merit of studies to ensure these fit within and programmatic focus of the CCCWFU. The PRC examines a protocol's relationship to the institutional cancer patient population and unmet patient needs and assesses the feasibility of a proposed protocol's accrual target. The committee assigns protocol priority as follows: 1) institutional investigator-initiated protocols, 2) cooperative groups, and 3) industry studies. Within these groups, emphasis is given to those protocols which target CCCWFU Program goals. The POW evaluates the operational and logistical feasibility and resources requirements of protocols in development. The POW reports its findings to the PRC. Protocol development is completed by a formal review process, with peer-reviewed evaluation of protocols by members of the PRC. The PRC also reviews all amendments to protocols. Protocol monitoring occurs throughout the span of patient accrual and analysis. Ongoing safety analysis is accomplished by the Clinical Research Oversight Committee (CROC) and the data safety and monitoring board (described in section 12). In addition, the Biostatistics shared resource and informatics groups provide interim analyses to facilitate the process of protocol monitoring.