Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10245198
• 负责人: ANTONIO TITO FOJO
• 金额: $ 14.82万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-07-04 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10245198
• 关键词: Address; Affect; Amendment; Cancer Center Support Grant; Cancer Intervention; Catchment Area; Clinical Research; Clinical Research Protocols; Collaborations; Complement; Data; Disease; Ensure; Goals; Herbert Irving Comprehensive Cancer Center; Institutional Review Boards; Intervention; Intervention Studies; Intervention Trial; Malignant Neoplasms; Medical center; Monitor; Process; Protocols documentation; Recommendation; Research; Research Priority; Resources; Review Committee; Safety; Scientific Evaluation; System; Time; Universities; Vision; Woman; age group; base; expedited review; innovation; programs; research study; sound; underserved minority

PROTOCOL REVIEW AND MONITORING SYSTEM: PROJECT SUMMARY The Herbert Irving Comprehensive Cancer Center (HICCC) Protocol Review and Monitoring System (PRMS) is responsible for independent scientific evaluation, prioritization, and monitoring of all cancer clinical research studies conducted at Columbia University Irving Medical Center (CUIMC). The PRMS is independent of and complements the activities of the Institutional Review Boards (IRBs) and HICCC Data Safety and Monitoring Committee (DSMC). The PRMS encompasses activities of the HICCC Disease Based Teams, Feasibility Committee, and Protocol Review and Monitoring Committee (PRMC). Although independently managed, these entities maintain close interactions and collaborations. The Specific Aims of the HICCC PRMS are the following: (1) Provide scientific review and prioritization of all applicable cancer-related clinical research protocols within the HICCC, (2) Monitor the progress of ongoing studies to ensure that accrual is sufficient to meet scientific objectives, (3) Determine whether trials should continue or close for lack of scientific progress, and (4) Assess and implement the recommendations of the Data Safety and Monitoring Committee (DSMC) regarding issues that may affect the scientific integrity of interventional trials. The process for review of cancer clinical research studies through the PRMS are as follows:  Disease Based Teams: Assess new trials for scientific value, fit and prioritization with existing disease-based research portfolios  Feasibility Committee: Review protocol feasibility to determine that adequate resources are in place prior to PRMC review  PRMC: Evaluate interventional protocols for scientific merit, innovation, and statistical soundness so as to assess their priority at initial submission. The PRMC also assess the scientific and accrual progress of interventional cancer trials at the time of continuing review. In 2018, the PRMC monitored 381 active interventional studies. The PRMC reviewed 128 new studies (full board review: 96; expedited review: 32) and 448 amendments. 1

协议审查和监视系统：项目摘要 赫伯特·欧文综合癌症中心（HICCC）方案审查和监测系统（PRMS）是 负责对所有癌症临床研究的独立科学评估，优先级和监测 在哥伦比亚大学欧文医学中心（CUIMC）进行的研究。 PRM独立于， 完成机构审查委员会（IRB）和HICCC数据安全和监视的活动 委员会（DSMC）。 PRM包括基于HICCC疾病的团队的活动，可行性 委员会以及协议审查与监测委员会（PRMC）。尽管独立管理，但 实体保持紧密的互动和协作。 HICCC PRM的具体目的如下： （1）提供科学审查并优先考虑所有适用的癌症相关临床研究方案 HICCC，（2）监视正在进行的研究的进展，以确保准确性足以满足科学 目标，（3）确定试验是否应继续或缺乏科学进步，以及（4）评估 并实施有关问题的数据安全与监测委员会（DSMC）的建议 这可能会影响介入试验的科学完整性。 通过PRM审查癌症临床研究的过程如下： 基于疾病的团队：评估新试验的科学价值，合适和优先级的现有基于疾病的试验 研究组合 可行性委员会：审查协议可行性，以确定在 PRMC评论 PRMC：评估介入方案的科学功绩，创新和统计健全性，以便 评估其初步提交时的优先级。 PRMC还评估了科学和准确的进步 持续审查时进行介入的癌症试验。 2018年，PRMC监测了381项主动介入研究。 PRMC审查了128项新研究（完整的董事会 评论：96;加急评论：32）和448个修正案。 1