Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10670859
• 负责人: JONATHAN C TRENT
• 金额: $ 4.05万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-10 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10670859
• 关键词: Authorization documentation; Basic Science; Bioinformatics Shared Resource; Biological; Biometry; Cancer Center Support Grant; Cancer Therapy Evaluation Program; Catchment Area; Clinical; Clinical Research; Clinical Sciences; Complement; Comprehensive Cancer Center; Data; Disease; Ensure; Faculty; Goals; Institutional Review Boards; Malignant Neoplasms; Medical; Mission; Monitor; Patients; Peer Review; Population Sciences; Procedures; Process; Protocols documentation; Research; Research Design; Research Personnel; Review Committee; Safety; Services; Site; Strategic Planning; System; United States National Institutes of Health; Universities; Vision; anticancer research; authority; biobehavior; design; epidemiology study; expedited review; experience; human subject protection; member; programs; recruit; research study

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM The Protocol Review and Monitoring System (PRMS) at the Sylvester Comprehensive Cancer Center (Sylvester) oversees all cancer-related clinical and population science research conducted at the University of Miami. The main aims of the PRMS are to 1) provide timely review of the scientific merit of all cancer research studies; 2) ensure prioritization of cancer research studies according to Sylvester’s strategic plan, mission, and vision, including programmatic alignment and catchment area relevance; and 3) monitor the scientific progress of all cancer research studies. PRMS functions are accomplished by a two-stage rigorous review process. First, the Site Disease Groups (SDG) assess scientific and clinical value, patient availability, and priority within the existing research portfolio. Second, studies are reviewed by the Protocol Review and Monitoring Committee (PRMC) composed of reviewers with the depth and breadth of expertise necessary to conduct a critical and fair review of all protocols. In 2017, Sylvester subdivided the PRMC, creating a subcommittee for population science studies (PRMC-PS), composed of faculty with expertise in population science, biobehavioral, and epidemiologic studies and a subcommittee for medical studies (PRMC-M), composed of faculty experienced in clinical, translational, and biological studies. Both subcommittees include members from the Biostatistics and Bioinformatics Shared Resource and members with basic science expertise, and they operate under the same standard operating procedures. PRMC scientific review takes into account the specific rationale, study design, availability of adequate numbers of patients or subjects, presence of any competing studies, and robustness of biostatistical design, assuring internal oversight of the scientific merit of all cancer studies. The functions of PRMC complement, rather than overlap or duplicate, the Institutional Review Board (IRB), which is responsible for the protection of human subjects. Further, the PRMC does not perform any auditing or data and safety monitoring functions. The PRMC does not duplicate traditional peer review for studies supported by various NIH mechanisms (e.g., R01s, U01s, P01s, U10s, and P50s) or approved by the NCI’s Cancer Therapy Evaluation Program. These protocols receive an expedited review for the purposes of prioritization. All studies are reviewed annually to evaluate scientific progress and continuing clinical and scientific relevance and importance; accruals are monitored every six months to ensure the study’s scientific design and that accrual is proceeding sufficiently to support the overall objectives of the study. Sylvester’s PRMC is administrated by the Research Committees Support Unit staff within Clinical Research Services. The PRMC has the final authority to close cancer studies not meeting scientific or accrual goals. Having a robust PRMS, which includes both the SDG and the PRMC review processes, is critical to ensure the highest quality cancer and cancer-related research is conducted by Sylvester investigators.

项目摘要：方案审查和监测系统 西尔维斯特综合癌症中心的方案审查和监测系统（PRMS） （西尔维斯特）负责监督所有癌症相关的临床和人口科学研究在大学进行的。 迈阿密。PRMS的主要目的是：1）及时审查所有癌症研究的科学价值 研究; 2）根据西尔维斯特的战略计划、使命，确保癌症研究的优先顺序，以及 愿景，包括计划的一致性和集水区的相关性;以及3）监测科学进展 所有癌症研究中最重要的PRMS的功能是通过两个阶段的严格审查过程来完成的。 首先，研究中心疾病组（SDG）评估科学和临床价值、患者可用性以及 现有的研究项目。第二，研究由方案审查和监测小组审查， 委员会（PRMC）由审查员组成，他们具有进行审查所需的专业知识的深度和广度。 对所有方案进行严格和公正的审查。2017年，西尔维斯特将PRMC细分，成立了一个小组委员会， 人口科学研究（PRMC-PS），由具有人口科学专门知识的教师组成， 生物行为和流行病学研究，以及医学研究小组委员会（PRMC-M），由以下人员组成： 教师在临床，翻译和生物学研究经验丰富。两个小组委员会的成员来自 生物统计学和生物信息学共享资源和具有基础科学专业知识的成员，他们 在相同的标准操作程序下运行。PRMC科学审查考虑到了具体的 依据、研究设计、足够数量的患者或受试者的可用性、是否存在任何竞争 生物统计设计的稳健性，确保对所有癌症的科学价值进行内部监督 问题研究PRMC的职能与机构审查委员会相辅相成，而不是重叠或重复 (IRB)，负责保护人类受试者。此外，PRMC不执行任何 审计或数据和安全监控功能。PRMC不重复传统的同行评审， 由各种NIH机制支持的研究（例如，R 01、U 01、P01、U10和P50）或经 NCI癌症治疗评估计划。这些协议接受快速审查，目的是 优先化。每年对所有研究进行审查，以评估科学进展和持续的临床和 科学相关性和重要性;每六个月监测一次应计费用，以确保研究的科学性 设计，并且正在进行的累积足以支持研究的总体目标。西尔维斯特的 PRMC由临床研究服务部内的研究委员会支持部门工作人员管理。的 PRMC有最终权力关闭不符合科学或应计目标的癌症研究。具有坚固 PRMS包括SDG和PRMC审查流程，对于确保最高质量至关重要 癌症和癌症相关研究由西尔维斯特研究人员进行。