PROTOCOL REVIEW AND MONITORING SYSTEM

方案审查和监测系统

• 批准号: 8135581
• 负责人: STEVEN Terry ROSEN
• 金额: $ 14.33万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8135581
• 关键词: Amendment; Biometry; Cancer Center; Charge; Clinical Oncology; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Data Monitoring Committees; Complement; Comprehensive Cancer Center; Data; Development; Discipline; Discipline of Nursing; Disease; Ensure; Goals; Institution; Laboratories; Letters; Medical center; Monitor; Monitoring Clinical Trials; Peer Review; Pharmacy facility; Phase; Principal Investigator; Process; Protocols documentation; Reporting; Research Ethics Committees; Research Personnel; Safety; Science; Serious Adverse Event; System; United States National Institutes of Health; Universities; meetings; multidisciplinary; oncology; pilot trial; sound

The Clinical Protocol Scientific Review and Monitoring System (CPSRMS) of the Robert H. Lurie Comprehensive Cancer Center (Cancer Center) is composed of several key committees including the Clinical Protocol Scientific Review and Monitoring Committee (CPSRMC), Data Monitoring Committee (DMC), and the Audit Committee. The CPSRMC is charged with the responsibility of evaluating all new and ongoing clinical research protocols for scientific merit and institutional priority. This is required for all studies that have not received review and approval from an NCI-approved external peer review group. The CPSRMC is a multidisciplinary committee that consists of a core group providing the necessary expertise in the principal disciplines of clinical oncology with additional representation from Biostatistics, Laboratory Science, Pharmacy, and Nursing. The CPSRMC is directly responsible for: 1) reviewing new clinical trials to ensure that they are scientifically sound, 2) ensuring study priority has been assigned appropriately by the study Principal Investigator, 3) confirming that the clinical trials are relevant to the goals of the Cancer Center, 4) reviewing for adequacy of data and safety monitoring plans for each new protocol, 5) reviewing and approving all letters of intent prior to development of a local investigator-initiated clinical trial, and 6) reviewing and approving protocol amendments prior to IRB submission. The CPSRMS delegates responsibility for data and safety monitoring of clinical trials to the DMC and Audit Committee, whose activities are described in more detail in section 12.0, Data and Safety Monitoring.

Robert H. Lurie 的临床方案科学审查和监测系统 (CPSRMS) 综合癌症中心（Cancer Center）由几个主要委员会组成，包括 临床方案科学审查和监测委员会（CPSRMC）、数据监测委员会 （DMC）和审计委员会。 CPSRMC 负责评估所有新的和 正在进行的临床研究协议的科学价值和机构优先权。这是所有研究都需要的 尚未获得 NCI 批准的外部同行评审小组的评审和批准。这 CPSRMC 是一个多学科委员会，由一个提供必要专业知识的核心小组组成 临床肿瘤学的主要学科以及生物统计学、实验室的其他代表 科学、药学和护理。 CPSRMC 直接负责： 1) 审查新的临床试验，以 确保它们在科学上是合理的，2）确保研究优先级已由研究机构适当分配 研究首席研究员，3) 确认临床试验与癌症目标相关 中心，4) 审查每个新方案的数据和安全监测计划的充分性，5) 审查 并在开展当地研究者发起的临床试验之前批准所有意向书，以及 6) 在提交 IRB 之前审查和批准方案修正案。 CPSRMS 代表 DMC 和审计委员会负责临床试验的数据和安全监测，其 第 12.0 节“数据和安全监控”中更详细地描述了活动。