PROTOCOL REVIEW AND MONITORING SYSTEM (Core 013)

方案审查和监测系统（核心 013）

• 批准号: 8997282
• 负责人: Mark Edelstein
• 金额: $ 7.48万
• 依托单位: WAYNE STATE UNIVERSITY
• 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/8997282
• 关键词: Accounting; Basic Science; Biostatistics Core; Cancer Center; Cancer Center Support Grant; Cancer Patient; Cancer Therapy Evaluation Program; Clinical; Clinical Research Protocols; Clinical Trials; Committee Members; Data; Discipline; Discipline of Nursing; Ensure; Feasibility Studies; Guidelines; Industry; Institutional Review Boards; Left; Malignant Neoplasms; Mission; Monitor; Peer Review; Physician Assistants; Protocols documentation; Research; Research Design; Research Personnel; Research Support; Resource Allocation; Resources; Role; Safety; Source; Support System; System; Time; United States National Institutes of Health; abstracting; anticancer research; cancer clinical trial; human subject protection; medical specialties

PROTOCOL REVIEW AND MONITORING SYSTEM: ABSTRACT The Protocol Review and Monitoring System (PRMS) was first implemented in the early 1990s to oversee research involving cancer patients at KCI. The main objectives of the PRMS are to: 1) review the scientific merit of all cancer research protocols; 2) ensure prioritization of cancer protocols according to KCI's scientific priorities; and 3) monitor scientific progress. The Protocol Review and Monitoring Committee (PRMC) fulfills the primary role of the PRMS. The committee is composed of a complementary mix of investigators from various disciplines and specialties, as well as representatives from the Biostatistics Core, basic science, nursing and physician extenders, and administrative support staff from the Clinical Trials Office (CTO). The members of the committee represent a sufficient size and breadth of expertise to conduct a critical and fair scientific review of all clinical research protocols involving cancer patients at KCI. The PRMC provides internal oversight of the scientific merit of the cancer trials in addition to assuring that its clinical resources are engaged to ensure the best practices for scientific endeavors and applications. The function of the PRMC is complementary to that of the IRB, which focuses on the protection of human subjects. The PRMC is not intended to duplicate or overlap the responsibilities of the IRB, nor is it intended to perform an auditing or data and safety monitoring function. The PRMC evaluates all cancer clinical trials, whether derived and supported from NCTN, peer reviewed sources, institutional sources, or from industry. However, the PRMC does not duplicate the results of traditional peer review, which includes protocols supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s and P50s), and clinical research protocols approved by the NCI's Cancer Therapy Evaluation Program. These trials are still reviewed for competing studies, feasibility and resource allocation. Scientific review takes into account the specific rationale, study design, duplication of studies already in progress elsewhere and at the Cancer Center, adequacy of biostatistical input, and feasibility for completion of the study within a reasonable time frame. Additionally, the PRMC is responsible for accrual monitoring; protocols are reviewed regularly to evaluate scientific progress, including accrual rates, to ensure that the scientific aims of the study are on track for completion in the estimated timeframes indicated at initial submission.

协议审查和监视系统：摘要 协议审查和监控系统（PRMS）首次在1990年代初实施，以监督 KCI涉及癌症患者的研究。 PRM的主要目标是：1）审查科学 所有癌症研究方案的优点； 2）确保根据KCI的科学确保癌症方案的优先级 优先事项； 3）监控科学进步。协议审查和监测委员会（PRMC） 履行PRM的主要作用。该委员会由调查人员组成 来自各种学科和专业，以及来自生物统计学核心，基础科学的代表， 临床试验办公室（CTO）的护理和医师扩展员以及行政支持人员。这 委员会的成员代表了足够的专业知识，以进行关键和公平 对KCI涉及癌症患者的所有临床研究方案的科学综述。 PRMC提供内部 对癌症试验的科学优点的监督除了确保其临床资源参与 确保对科学努力和应用的最佳实践。 PRMC的功能是 与IRB的互补，重点是保护人类受试者。 PRMC不是 旨在重复或重叠IRB的职责，也不旨在执行审核或数据 和安全监控功能。 PRMC评估所有癌症临床试验，无论是衍生和支持的 从NCTN，同行审查了来源，机构来源或行业。但是，PRMC没有 复制传统同行评审的结果，其中包括由各种NIH机制支持的协议 （例如，R01S，U01S，P01，U10和P50）以及NCI癌症批准的临床研究方案 治疗评估计划。这些试验仍经过审查，以进行竞争研究，可行性和资源 分配。科学审查考虑了特定的理由，研究设计，研究的重复 在其他地方和癌症中心已经进展，生物统计输入的适当性以及可行性 在合理的时间范围内完成研究。此外，PRMC负责应计 监视；定期审查协议，以评估包括应计率在内的科学进步，以确保 该研究的科学目的是在最初指定的估计时间表中完成的 提交。