Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10611366
• 负责人: Wallace Lovell Akerley
• 金额: $ 5.62万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-09 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10611366
• 关键词: Area; Attention; Authorization documentation; Basic Science; Biometry; Cancer Center; Cancer Center Support Grant; Cancer Intervention; Cancer Patient; Catchment Area; Clinical; Clinical Protocols; Clinical Research; Clinical Sciences; Clinical Trials; Clinical assessments; Collaborations; Committee Membership; Concept Review; Detection; Disease; Ensure; Faculty; Goals; Hematology; Huntsman Cancer Institute at the University of Utah; Idaho; Image; Institution; Institutional Review Boards; Intervention; Investigation; Investigational Drugs; Investigational Therapies; Knowledge; Malignant Neoplasms; Medical Oncology; Mission; Monitor; Montana; National Comprehensive Cancer Network; Nevada; Oncology; Pathology; Patients; Pharmacy facility; Policies; Population; Population Sciences; Prevention; Procedures; Process; Protocols documentation; Radiation Oncology; Research; Research Activity; Resources; Review Committee; Running; Services; Site; Specimen Handling; System; Time; Translational Research; Treatment Protocols; Universities; Utah; Work; Wyoming; authority; biomedical referral center; cancer clinical trial; cancer therapy; data management; expectation; improved; investigator-initiated trial; knowledge integration; operation; programs; protocol development; rare cancer; success; trend

PROTOCOL REVIEW AND MONITORING SYSTEM ABSTRACT The Protocol Review and Monitoring System (PRMS) reviews and monitors all interventional cancer-related clinical trials at Huntsman Cancer Institute (HCI) and the University of Utah (U of U), providing critical support to the Cancer Center in its mission to create and improve cancer treatments, with the ultimate goal of relieving the suffering of cancer patients. The PRMS at HCI comprises three committees: the Institutional Protocol Development Committee (IPDC), the Feasibility Administrative Review Committee (FAR), and the Protocol Review and Monitoring Committee (PRMC). These three committees work in sequence, using a two-stage review process, with the IPDC and FAR in the first stage and PRMC in the second stage. These committees ensure that all cancer-related research activities are rigorous, relevant, impactful, meet the scientific priorities of the Center, and are feasible to complete. The IPDC reviews concepts of investigator-initiated trials to determine whether they are ready and appropriate for institutional support for protocol development. The IPDC assesses trial rationale, potential for significance, and possibility for collaboration and scientific correlates to take full advantage of Center resources. Concepts approved in this stage are advanced for full protocol development. The IPDC includes representatives from basic science, pathology, imaging, experimental therapeutics, medical oncology, hematology, radiation oncology, biostatistics, Investigational Drug Services, Clinical Trials Office, and Research Compliance Office. The FAR Committee conducts a review of interventional treatment protocols to examine the logistical operations associated with running the proposed study. The objective of FAR is to ensure all clinical trials supported by the Clinical Trials Office at HCI can feasibly be conducted at the institution and are resourced appropriately. FAR approval must be obtained prior to any financial or regulatory activation activities commencing. FAR does not do scientific reviews. FAR representatives include pharmacy, specimen processing, coordination and data management, clinical integration, imaging, and satellite site coordinators. The PRMC provides internal oversight of interventional cancer clinical trials by evaluating the scientific merit, priorities, and progress of clinical research of the Center. The PRMC has the authority to open trials that meet the standards and scientific priorities of the Center and to terminate trials that do not demonstrate scientific progress. The PRMC membership includes broad and extensive expertise in oncology research to ensure that review of clinical protocols and assessment of progress is conducted at the highest scientific level. The PRMC monitors accrual trends and sets scientific standards for interventional clinical trials.

方案审查和监测系统 摘要 方案审查和监测系统（PRMS）审查和监测所有与癌症相关的介入性治疗。 亨斯迈癌症研究所（HCI）和犹他州大学（U of U）的临床试验，提供关键支持 癌症中心的使命是创造和改善癌症治疗，最终目标是缓解 癌症患者的痛苦。HCI的PRMS由三个委员会组成： 国际传播发展计划（IPDC）、可行性行政审查委员会（FAR）和议定书 审查和监测委员会。这三个委员会按顺序工作，采用两阶段 国际传播发展计划和《非洲发展报告》处于第一阶段，PRMC处于第二阶段。这些委员会 确保所有与癌症相关的研究活动都是严格的，相关的，有影响力的，符合科学优先事项 中心的，并且是可行的。 国际传播发展计划（IPDC）审查由仲裁员发起的试验的概念，以确定它们是否准备就绪和适当 为协议制定提供机构支持。国际传播发展计划评估了试验的基本原理、潜在的重要性， 以及合作和科学相关性的可能性，以充分利用中心的资源。概念 在此阶段获得批准的项目将提前进行全面的方案制定。国际传播发展计划包括来自以下国家的代表： 基础科学、病理学、影像学、实验治疗学、医学肿瘤学、血液学、放射学 肿瘤学、生物统计学、研究药物服务、临床试验办公室和研究合规办公室。 FAR委员会对介入治疗方案进行审查， 与运行建议研究相关的操作。FAR的目标是确保所有临床试验 在HCI临床试验办公室的支持下，可以在该机构进行，并获得资源 适当地。在进行任何财务或监管激活活动之前，必须获得FAR批准 开始。FAR不做科学评论。FAR代表包括药房、标本 处理、协调和数据管理、临床整合、成像和卫星站点协调员。 PRMC通过评估科学价值， 中心临床研究的重点和进展。PRMC有权开启符合以下条件的试验 该中心的标准和科学优先事项，并终止不证明科学的试验 中求进工作总PRMC成员包括广泛而广泛的肿瘤学研究专业知识，以确保 在最高科学水平上审查临床方案和评估进展。PRMC 监测累积趋势，并为干预性临床试验制定科学标准。