Protocol Review and Monitoring System (PRMS)

方案审查和监控系统 (PRMS)

• 批准号: 10554303
• 负责人: LIONEL David LEWIS
• 金额: $ 7.1万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-08-04 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10554303
• 关键词: Advocacy; Amendment; Authorization documentation; Basic Science; Biomedical Engineering; Biometry; Cancer Center; Cancer Center Support Grant; Charge; Clinical; Clinical Cancer Center; Clinical Oncology; Clinical Pharmacology; Clinical Research; Clinical Trials; Collection; Committee Members; Communication; Data; Discipline; Enrollment; Funding Agency; Hematology; Immunology; Institutional Review Boards; Intervention; Intervention Trial; Light; Logistics; Malignant Neoplasms; Medical Oncology; Modification; Monitor; NCI Center for Cancer Research; Norris Cotton Cancer Center; Oncology; Oncology Group; Participant; Pathology; Patient Outcomes Assessments; Pediatric Oncology; Peer Review; Population; Population Sciences; Principal Investigator; Process; Protocols documentation; Published Comment; Quality of life; Radiation Oncology; Recommendation; Regulation; Research; Research Activity; Review Committee; Safety; Suggestion; Surgical Oncology; System; Time; United States National Institutes of Health; authority; behavioral study; cancer prevention; college; falls; human subject; human subject protection; member; multidisciplinary; participant safety; patient population; programs; research study; safety outcomes; screening; survivorship

Project Summary/Abstract: Protocol Review and Monitoring System The Norris Cotton Cancer Center (NCCC) has established a process by which clinical trials/population science studies proposed by Cancer Center Members undergo internal peer review. This review must occur prior to local Institutional Review Board (i.e., the Dartmouth College Committee for the Protection of Human Subjects [CPHS]) submission and review. The protocol review and monitoring system is overseen by the protocol review and monitoring committee (PRMC) which at NCCC is known as the Clinical Cancer Review Committee (CCRC). The CCRC is responsible for assessing the scientific validity of proposed studies, determining their prioritization and feasibility in light of the availability of human subjects and current protocols relying on enrollments from that same patient population, assuring that the safety monitoring plan is appropriate and in accordance with regulations, and where necessary offering constructive comments that enhance either scientific merit or implementation logistics of the proposed clinical study. The NCCC CCRC is a chartered multidisciplinary committee charged with reviewing all non-NCI Cooperative group research protocols and amendments proposed to be opened by Dartmouth Principal Investigators (PIs) for treatment of, and intervention for, cancer. Cancer prevention studies, screening trials, behavioral studies, quality of life/survivorship studies, and interventional trials that rely on collection of patient-reported outcomes that have not already undergone external peer review by NIH and its funding agencies are reviewed by the Population Science Subcommittee (PSS) of the CCRC. The CCRC has the ultimate authority to approve, require modifications, or disapprove of research activities and terminate studies that fall within its jurisdiction. Situations where CCRC will close studies include when they have a negative safety outcome, have low accrual, or if the study will not achieve its scientific objectives. CCRC members are selected to represent the broad spectrum of oncology expertise. Cadre membership includes representatives from medical oncology, hematology, surgical oncology, pediatric oncology, clinical pharmacology, biostatistics, basic science research, population science, clinical research administration, and research participant advocacy. Other disciplines, such as Radiation Oncology, Pathology, Immunology and translational biomedical engineering, are represented by members on an ad-hoc basis when a proposed clinical trial features such components in its main objectives.

项目摘要/摘要：方案审查和监控系统 Norris Cotton 癌症中心 (NCCC) 建立了一个流程，通过该流程进行临床试验/人口科学 癌症中心成员提出的研究要经过内部同行评审。该审查必须在 当地机构审查委员会（即达特茅斯学院人类受试者保护委员会 [CPHS]）提交和审查。方案审查和监控系统由方案监督 审查和监督委员会 (PRMC)，在 NCCC 被称为临床癌症审查委员会 （CCRC）。 CCRC 负责评估拟议研究的科学有效性，确定其研究成果 根据人类受试者的可用性和当前协议的优先顺序和可行性 来自同一患者群体的登记，确保安全监测计划适当且符合要求 按照规定，并在必要时提出建设性意见，以加强 拟议临床研究的科学价值或实施逻辑。 NCCC CCRC 是一个特许多学科委员会，负责审查所有非 NCI 合作组织 达特茅斯首席研究员 (PI) 建议开放的小组研究方案和修正案 用于治疗和干预癌症。癌症预防研究、筛查试验、行为研究、 生活质量/生存研究以及依赖于收集患者报告结果的介入试验 尚未经过 NIH 及其资助机构的外部同行评审的项目由 CCRC 人口科学小组委员会 (PSS)。 CCRC拥有最终批准权， 要求修改或不批准研究活动并终止属于其管辖范围的研究。 CCRC 将关闭研究的情况包括当研究结果呈负面、安全性较低时 权责发生制，或者研究无法实现其科学目标。 CCRC 成员的选拔代表了广泛的肿瘤学专业知识。干部会员资格 包括来自肿瘤内科、血液科、外科肿瘤科、儿科肿瘤科、临床科的代表 药理学、生物统计学、基础科学研究、人口科学、临床研究管理等 研究参与者的倡导。其他学科，如放射肿瘤学、病理学、免疫学和 转化生物医学工程，当提出建议时，由成员临时代表 临床试验的主要目标中包含这些组成部分。