Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10443650
• 负责人: JONATHAN C TRENT
• 金额: $ 3.93万
• 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/10443650
• 关键词: 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; Time; 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：协议审查和监视系统 西尔维斯特综合癌症中心的协议审查和监测系统（PRMS） （Sylvester）监督在大学进行的所有与癌症有关的临床和人群科学研究 迈阿密。 PRM的主要目的是1）及时审查所有癌症研究的科学优点 研究； 2）确保根据西尔维斯特的战略计划，使命和 愿景，包括程序对齐和集水区相关性； 3）监控科学进步 在所有癌症研究中。 PRMS功能是通过两个阶段严格的审查过程来完成的。 首先，现场疾病组（SDG）评估科学和临床价值，患者可用性以及优先级 现有的研究组合。其次，协议审查和监视对研究进行了审查 由审阅者组成的委员会（PRMC），具有深度和广度的专业知识 所有协议的批判性审查。 2017年，西尔维斯特（Sylvester）细分了PRMC，创建了一个小组委员会 人群科学研究（PRMC-PS）由具有人口科学专业知识的教师组成， 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 临床，翻译和生物学研究经验丰富的教师。两个小组委员会都包括来自 生物统计学和生物信息学家共享资源和具有基础科学专业知识的成员，他们 根据相同的标准操作程序进行操作。 PRMC科学评论考虑了具体的 基本原理，研究设计，足够数量的患者或受试者的可用性，存在任何竞争 研究和生物统计设计的鲁棒性，确保内部对所有癌症的科学优点的监督 研究。 PRMC完成的功能，而不是重叠或重复，机构审查委员会 （IRB），负责保护人类受试者。此外，PRMC不执行任何 审核或数据以及安全监控功能。 PRMC不会复制传统的同行评审 由各种NIH机制（例如R01，U01S，P01，U10和P50）支持的研究或由 NCI的癌症治疗评估计划。这些协议就以 优先级。每年审查所有研究，以评估科学进步和持续的临床和 科学相关性和重要性；每六个月监控每六个月的累积，以确保研究的科学 设计和准确性正常进行，以支持研究的总体目标。西尔维斯特的 PRMC由研究委员会在临床研究服务中为单位人员提供支持。这 PRMC拥有关闭癌症研究的最终权力，而不必达到科学或口音目标。有一个健壮的 PRMS包括可持续发展目标和PRMC审查过程，对于确保最高质量至关重要 癌症和与癌症有关的研究由Sylvester研究者进行。