Protocol Review and Monitoring System (PRMS)

方案审查和监控系统 (PRMS)

• 批准号: 10311241
• 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/10311241
• 关键词: Advocacy; Amendment; 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; 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; base; 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：协议审查和监视系统 诺里斯棉花癌中心（NCCC）已经建立了一个临床试验/人口科学的过程 癌症中心成员提出的研究接受了内部同行评审。该评论必须在 地方机构审查委员会（即达特茅斯学院保护人类受试者委员会 [CPHS]）提交和审查。协议审核和监视系统由协议监督 NCCC的审查和监测委员会（PRMC）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，并确定其 鉴于人类受试者的可用性和当前协议的可用性和可行性 同一患者人群的注册，确保安全监控计划适当，并且 根据法规，并在必要时提供建设性评论以增强任何一种 拟议临床研究的科学优点或实施后勤。 NCCC CCRC是一个由特许的多学科委员会，负责审查所有非NCI合作社 小组研究方案和修正案提议由达特茅斯首席研究人员（PIS）开放 用于治疗癌症和干预措施。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患者报告的结果的介入试验 NIH尚未经过外部同行评审及其资助机构的审查 CCRC的人口科学小组委员会（PSS）。 CCRC拥有批准的最终权力， 需要修改或不赞成研究活动并终止其管辖范围内的研究。 CCRC将关闭研究包括负面安全性结果，较低的情况包括 应计，或者该研究无法实现其科学目标。 选择CCRC成员代表广泛的肿瘤学专业知识。干部会员资格 包括医学肿瘤学，血液学，外科肿瘤学，小儿肿瘤学，临床的代表 药理学，生物统计学，基础科学研究，人群科学，临床研究管理局和 研究参与者的倡导。其他学科，例如辐射肿瘤学，病理学，免疫学和 当提议时，会员在临时代表转化生物医学工程 临床试验以此类组件为主要目标。