Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 9282719
• 负责人: KAREN E KNUDSEN
• 金额: $ 7.59万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9282719
• 关键词: Area; Basic Science; Cancer Center; Chairperson; Clinical; Clinical Cancer Center; Clinical Research; Clinical Trials; Communication; Data; Disease; Doctor of Medicine; Doctor of Philosophy; Documentation; Evaluation; Goals; Institutional Review Boards; Instruction; Investigational Therapies; Malignant Neoplasms; Methods; Monitor; NCI Center for Cancer Research; Names; Office Management; Patients; Pharmacology; Population; Principal Investigator; Protocol Compliance; Protocols documentation; Recommendation; Research Personnel; Research Proposals; Resources; Review Committee; Risk; Safety; Stratification; System; Therapeutic; Translational Research; Universities; anticancer research; authority; base; clinical investigation; experience; human subject; meetings; multidisciplinary; neoplastic; ranpirnase; response

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.

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（参见说明）：方案审查和监测系统 Kimmel 癌症中心 (KCC) 的方案审查和监测系统 (PRMS) 是 KCC 临床研究活动的一个组成部分。 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。相关多学科疾病小组对方案进行首次审查，该小组对方案可行性、缺乏竞争性方案或分层（如果与其他方案存在重叠）以及与 KCC 研究和权责发生制目标的兼容性提供书面评估。该评估由特定的多学科疾病小组负责人签署。临床研究管理办公室 (CRMO) 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 Kimmel 癌症中心研究人员组成的审查委员会（由基础科学和临床领域的代表组成），负责对所有正在进行的临床试验进行初步科学审查和监测； (2) 评估新提案的科学价值（研究价值、方法、统计价值、研究者经验和患者资源）； (3) 制定金梅尔癌症中心竞争性研究的优先顺序标准； (4) 监测试验的患者应计指标； (5) 与托马斯杰斐逊大学机构审查委员会和金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； (6) 通过监测持续审查的科学进展，确保方案合规性。 CCRRC 对每项拟议研究的初步科学审查侧重于： (1) 研究价值； （二）方法； (3) 研究者经验 (4) 风险和 (5) 数据和安全监测计划。