Protocol Review and Monitoring System

方案审查和监测系统首席研究员：Pestell，Richard G.，M.D.，Ph.D.(P30 CA056036)项目摘要(见说明)：方案审查和监测系统金梅尔癌症中心(KCC)的方案审查和监测系统(PRMS)是KCC临床研究活动不可或缺的组成部分。KCC PRMS被命名为癌症临床研究审查委员会(CCRRC)。CCRRC审查所有涉及人类受试者和肿瘤疾病的新研究提案。协议接受相关多学科疾病小组的第一次审查，该小组提供对协议可行性、缺乏竞争性协议或分层(如果存在与其他协议重叠)以及与KCC研究和应计目标的兼容性的书面评估。这项评估由特定的多学科疾病小组组长签署。临床研究管理办公室(CRMO)的工作人员为CCRRC准备文件并协调会议和沟通。CCRRC的具体目标是：(1)维持一个由基梅尔癌症中心研究人员(来自基础科学和临床领域的代表)组成的审查委员会，负责对所有正在进行的临床试验进行初步的科学审查和监测；(2)评估新提案的科学价值(研究价值、方法、统计价值、研究人员经验和患者资源)；(3)为相互竞争的基梅尔癌症中心研究建立优先标准；(4)监测患者应计指标的试验；(5)与托马斯·杰斐逊大学机构审查委员会和基梅尔癌症中心数据和安全监测委员会(DSMC)保持合作关系，以促进三个审查委员会之间的互动；以及(6)通过监测正在进行的审查科学进展，确保遵守议定书。CCRRC对每项拟议研究的初步科学审查侧重于：(1)研究价值；(2)方法；(3)调查员(S)的经验；(4)风险；(5)数据和安全监测计划。

Protocol Review and Monitoring System Principal Investigator: Pestell, Richard G., M.D., Ph.D. (P30 CA056036) PROJECT SUMMARY (See Instructions): PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) of the Kimmel Cancer Center (KCC) is an integral component of the KCC clinical investigations activities. The KCC PRMS is named the Cancer Clinical Research Review Committee (CCRRC). The CCRRC reviews all new research proposals involving human subjects and neoplastic diseases. Protocols receive a first review by the pertinent Multidisciplinary Disease Group, which provides a written evaluation of protocol feasibility, lack of competitive protocols or stratification if overlap with other protocols exists, and compatibility with KCC research and accrual goals. This evaluation is signed off by the specific Multidisciplinary Disease Group Leader. The Clinical Research Management Office (CRMO) staff prepares the documentation and coordinates meetings and communications for the CCRRC. The specific aims of the CCRRC are: (1) to maintain a review committee of Kimmel Cancer Center investigators (with representation from basic science and clinical areas) responsible for the initial scientific review and monitoring of all ongoing clinical trials; (2) to evaluate the scientific merit of new proposals (study value, methods, statistical merit, investigator experience, and patient resources); (3) to establish criteria for the prioritization of competing Kimmel Cancer Center studies; (4) to monitor trials for patient accrual metrics; (5) to maintain a collaborative relationship with the Thomas Jefferson University Institutional Review Board and the Kimmel Cancer Center Data and Safety Monitoring Committee (DSMC) to facilitate interaction between the three review committees; and (6) to assure protocol compliance through the monitoring of ongoing review scientific progress. The CCRRC initial scientific review of each proposed study focuses on: (1) study value; (2) methods; (3) investigator(s) experience (4) risk and (5) data and safety monitoring plans.