Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 8804792
• 负责人: PAUL J MARTIN
• 金额: $ 19.36万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-02-01 至 2019-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8804792
• 关键词: Affect; Biometry; Cancer Center Support Grant; Cancer Patient; Caring; Clinical Research; Disease; Enrollment; Ensure; Faculty; Foundations; Goals; Health Sciences; Human; Institutional Review Boards; Laboratories; Malignant Neoplasms; Medical Oncology; Mission; Monitor; Pathology; Pediatric Nursing; Pharmacy facility; Population; Protocols documentation; Public Health; Radiation therapy; Rare Diseases; Research; Research Personnel; Research Support; Resources; Review Committee; Role; Science; Staging; Surgical Oncology; System; cancer imaging; complement system; design; human subject protection; innovation; meetings; member; multi-site trial; multidisciplinary; named group; patient population; prevent; sound

PRMS Summary The Protocol Review and Monitoring System (PRMS) provides essential support for the research mission of the FHCRC/UW Cancer Consortium in conducting clinical research. Results of this research help to define the best ways to prevent cancer and to treat and care for those affected by cancer. PRMS activities help ensure that efforts focus on protocols of the highest quality and most innovative character. These activities also help ensure that cancer patients served by the Consortium have opportunities to participate in studies matching the types and stages of diseases that occur in this population. The PRMS ensures that cancer- relevant human research is scientifically important, has a sound biostatistical foundation and supports the research mission of the Consortium. The PRMS also ensures that research is designed appropriately without excluding special populations for non-scientific reasons and is feasible, with reasonably attainable accrual targets given the available patient population. The Scientific Review Committee (SRC) has the primary role in the PRMS. Members of the SRC have deep, multidisciplinary expertise, including medical oncology, surgical oncology, radiation therapy, pediatrics, nursing, pathology, laboratory sciences, cancer imaging, pharmacy and biostatistics. Portfolios of research protocols are organized and maintained by defined Research Groups, each led by a senior faculty member. The SRC conducts an independent review of all new protocols and has well-defined approval criteria designed to ensure that goals of the PRMS are met. The SRC also reviews accrual and scientific progress for each study at 6-month intervals in order to ensure efficient use of resources, using well-defined approval criteria for continued accrual. Allowances are made for trials that focus on a rare disease or condition, those that are narrowly targeted, for investigator- initiated trials that have outstanding scientific merit, and for multi-site trials that are making adequate overall progress even if enrollment at the Consortium is low. The PRMS complements, but does not overlap with the functions or role of the IRB, which functions independently and is focused on human subjects protection.

PRMS总结 方案审查和监测系统（PRMS）为以下研究使命提供了必要的支持： FHCRC/UW癌症联盟进行临床研究。这项研究的结果有助于定义 最好的方法来预防癌症和治疗和照顾那些受癌症影响。PRMS活动有帮助 确保各项努力侧重于最高质量和最具创新性的议定书。这些活动 也有助于确保联盟服务的癌症患者有机会参与研究 与这个人群中发生的疾病类型和阶段相匹配。PRMS确保癌症- 相关的人类研究在科学上具有重要意义，具有良好的生物统计学基础， 财团的研究使命。PRMS还确保研究设计得当 不因非科学原因排除特殊人群，并且是可行的， 考虑到可用的患者人群，科学审查委员会（SRC） 在PRMS中的主要角色。SRC的成员拥有深厚的多学科专业知识，包括医疗 肿瘤学、外科肿瘤学、放射治疗、儿科学、护理学、病理学、实验室科学、癌症 成像、药学和生物统计学。研究方案的组合由以下人员组织和维护： 定义了研究小组，每个小组由一名高级教职员工领导。SRC进行独立审查 所有新方案，并具有明确的批准标准，旨在确保PRMS的目标 met. SRC还每6个月审查一次每项研究的累积和科学进展， 确保有效利用资源，使用明确的持续应计核准标准。津贴 用于关注罕见疾病或病症的试验，那些针对性较窄的试验，供研究者使用- 启动的试验具有突出的科学价值，多中心试验，使充分的整体 即使联盟的注册人数很低，也会取得进展。PRMS补充，但不重叠 IRB的职能或作用，其独立运作并专注于人类受试者保护。