Protocol Review and Monitoring (PRMS)

项目概要/摘要（描述）：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，癌症中心成员接受 对拟议的临床试验和人口科学的科学价值和优先次序进行内部同行审查 机构审查委员会审查前的方案（即，达特茅斯保护人权委员会 受试者[CPHS]）。这些NCCC审查是为了确认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，研究的可行性依赖于 从相同人群中入组，以确保安全性监测计划适当且符合 并提供意见，以加强科学价值或执行后勤工作， 计划的研究。 NCCC的临床癌症研究委员会（CCRC）是一个特许的多学科委员会，负责 审查所有非NCI合作组研究方案和修正案， 达特茅斯癌症治疗和干预的主要研究者（PI）。癌症预防 研究、筛选试验、行为研究、生活质量/生存率研究和干预性试验， 依赖于收集尚未经过NIH外部同行评审的患者报告结果 及其资助机构由CCRC人口科学小组委员会（PSS）审查。CCRC已 批准、要求修改或不批准其范围内的研究活动的权力 辖区 CCRC成员被选中代表广泛的肿瘤学研究。干部党员 包括肿瘤内科、血液学、肿瘤外科、儿科肿瘤科、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 病人辩护其他学科，如放射肿瘤学，病理学和免疫学的代表 当临床试验的主要目的包括这些成分时，委员会可按个别情况作出决定。

Project Summary/Abstract (Description): Protocol Review & Monitoring System Norris Cotton Cancer Center (NCCC) has established a process by which Cancer Center Members undergo internal peer review of the scientific merit and prioritization of proposed clinical trials and population science protocols prior to Institutional Review Board review (i.e., Dartmouth's Committee for the Protection of Human Subjects [CPHS]). These NCCC reviews are to confirm the scientific validity of the proposed study, to assess the feasibility of the study in light of the availability of human subjects and current protocols relying on enrollments from that same population, to assure the safety monitoring plan is appropriate and in accordance with regulations, and to offer comments that could enhance either scientific merit or implementation logistics of the planned study. NCCC's Clinical Cancer Research Committee (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 CCRC Population Science Subcommittee (PSS). The CCRC has the authority to approve, require modifications in, or disapprove research activities that fall within its jurisdiction. CCRC members are selected to represent the broad spectrum of oncology research. Cadre membership includes representatives from medical oncology, hematology, surgical oncology, pediatric oncology, clinical pharmacology, biostatistics, basic science research, population science, clinical research administration, and patient advocacy. Other disciplines such as Radiation Oncology, Pathology and Immunology are represented by members on an ad-hoc basis when a clinical trial features such components in its main objectives.