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.

项目概要/摘要：方案审查和监测系统 诺里斯棉花癌症中心（NCCC）已经建立了一个过程，临床试验/人口科学 癌症中心成员提出的研究需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，达特茅斯学院保护人类受试者委员会 [CPHS]）提交和审查。方案审查和监测系统由方案监督 审查和监测委员会（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， 根据人类受试者的可用性和当前方案的优先顺序和可行性， 从同一患者人群中入组，确保安全性监测计划是适当的， 并在必要时提供建设性意见，以加强 拟定临床研究的科学价值或实施物流。 NCCC CCRC是一个特许的多学科委员会，负责审查所有非NCI合作社 提议由达特茅斯主要研究者（PI）开启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/生存率研究，以及依赖于收集患者报告结局的干预性试验 还没有经过NIH及其资助机构的外部同行评审的，由 CCRC的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：安全性结局为阴性， 如果研究不能实现其科学目标，则应进行评估。 CCRC成员被选中代表广泛的肿瘤学专业知识。干部党员 包括来自内科肿瘤学、血液学、外科肿瘤学、儿科肿瘤学、临床 药理学、生物统计学、基础科学研究、人口科学、临床研究管理，以及 研究参与者的支持。其他学科，如放射肿瘤学、病理学、免疫学和 翻译生物医学工程，是由成员在特设的基础上，当提出一个 临床试验在其主要目标中具有这些成分。