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.

协议审查和监测系统主要研究人员：Pestell，Richard G.，M.D。，博士学位（P30 CA056036）项目摘要（请参阅说明）：协议审查和监视系统Kimmel癌症中心（KCC）的协议审查和监视系统（PRMS）是KCC临床研究活动的组成部分。 KCC PRMS被命名为癌症临床研究审查委员会（CCRRC）。 CCRRC回顾了所有涉及人类受试者和肿瘤疾病的新研究建议。协议获得了相关的多学科疾病组的首次审查，该疾病群体提供了对协议可行性的书面评估，如果存在与其他方案重叠，以及与KCC研究和应计目标的兼容性，则缺乏竞争性方案或分层。该评估由特定的多学科疾病组领导者签署。临床研究管理办公室（CRMO）的工作人员准备了文档，并为CCRRC进行了协调会议和沟通。 CCRRC的具体目的是：（1）维持Kimmel癌症中心研究人员的审查委员会（来自基础科学和临床领域的代表），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）评估新建议的科学优点（研究价值，方法，统计优点，研究者经验和患者资源）； （3）建立竞争Kimmel癌症中心研究优先级的标准； （4）监视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）通过监视正在进行的审查科学进步来确保协议合规性。 CCRRC对每项研究的最初科学综述的重点是：（1）研究值； （2）方法； （3）研究者（S）经验（4）风险和（5）数据和安全监控计划。