Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10320886
• 负责人: AUTUMN J MCREE
• 金额: $ 15.17万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10320886
• 关键词: Address; Advocate; African American population; Area; Basic Science; Biometry; Cancer Center; Cancer Center Support Grant; Cancer Patient; Catchment Area; Clinical Data; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Sciences; Clinical Trials; Committee Members; Communities; Community Outreach; Consent; Data Management Resources; Dedications; Discipline; Disease; Ensure; Environment; Evaluation; Faculty; Funding; Future; Goals; Growth; Human Research Ethics; Infrastructure; Institutes; Institutional Review Boards; Intervention; Laboratories; Leadership; Learning; Malignant Neoplasms; Mentors; Minority; Monitor; North Carolina; Online Systems; Patients; Population; Population Sciences; Preparation; Problem Solving; Process; Protocols documentation; Research; Research Personnel; Resources; Review Committee; Role; Social Sciences; System; Time; Training and Education; UNC Lineberger Comprehensive Cancer Center; Underrepresented Minority; Universities; Voice; authority; base; cancer clinical trial; clinically relevant; community engagement; cost effective; data management; feasibility trial; improved; investigator-initiated trial; meetings; member; recruit

ABSTRACT: PROTOCOL REVIEW AND MONITORING SYSTEM The UNC Lineberger Comprehensive Cancer Center’s Protocol Review and Monitoring System (PRMS) facilitates internal oversight of the scientific aspects of all cancer clinical trials at the University of North Carolina focusing on the scientific merit, priorities, and progress of clinical protocol research. The system is a multi-step process with preliminary review by Protocol Office Disease teams (PODs) and the Resource and Feasibility Team (RAFT) followed by formal scientific review by the Protocol Review Committee (PRC). The PRC is chaired by Autumn McRee, MD, and meets bi-monthly to review every cancer-related clinical protocol before it is submitted to The Office of Human Research Ethics’ Institutional Review Board (IRB). The PRC’s primary function is to ensure the scientific quality of proposed studies. As described in Clinical Protocol and Data Management (CPDM), PODs and RAFT review protocols for feasibility, quality, and priority before they are submitted to the PRC. The PRC monitors study accrual and has the authority to close under- performing trials. During 2019, the PRC reviewed 392 protocols: 156 new studies and 236 active trials for renewal and monitoring. This represents an 8% increase over the PRMS activity at the time of our last renewal and reflects both our growth and dedication to an effective PRMS process.

摘要：协议审查和监视系统 UNC Lineberger综合癌症中心的协议审查和监测系统（PRMS） 促进北大学所有癌症临床试验的科学方面的内部监督 卡罗来纳州专注于临床方案研究的科学优点，优先事项和进步。该系统是 协议办公室疾病团队（POD）和资源和资源的多步骤过程以及 可行性团队（RAFT），然后由协议审查委员会（PRC）进行正式科学审查。 中国由医学博士Autumn McRee主持，并每两月见面以审查与癌症有关的所有临床 在将其提交给人类研究伦理学办公室的机构审查委员会（IRB）之前。这 中国的主要功能是确保拟议研究的科学质量。如临床方案中所述 以及数据管理（CPDM），POD和RAFT审核协议，以提供可行性，质量和优先级 他们被提交给中国。中国监视研究准确性，并有权关闭未经 进行试验。在2019年期间，中国审查了392个协议：156项新研究和236个主动试验 更新和监视。这代表我们上次续签时的PRMS活动增长8％ 并反映了我们对有效PRMS过程的增长和奉献精神。