Protocol Review and Monitoring (PRMS)

项目总结/摘要(描述)：协议审查和监测系统 诺里斯·科顿癌症中心(NCCC)已经建立了一个癌症中心成员经历的过程 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议定书(即达特茅斯保护人权委员会 科目[CPHS])。NCCC的这些审查是为了确认拟议研究的科学有效性，以评估 鉴于人体受试者的可用性和目前依赖于 从相同人口中登记，以确保安全监测计划是适当和符合的 并提供意见，以加强科学价值或实施后勤 计划中的研究。 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合作小组研究方案和修正案，建议由 达特茅斯大学癌症治疗和干预首席调查员(PI)。癌症预防 研究、筛查试验、行为研究、生活质量/生存研究和干预试验 依赖于尚未经过NIH外部同行审查的患者报告结果的收集 其资助机构由CCRC人口科学小组委员会(PSS)审查。中国证监会已将 批准、要求修改或不批准属于其范围内的研究活动的权力 司法管辖权。 CCRC成员被选为代表肿瘤学研究的广泛领域。干部党员 包括内科肿瘤学、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、临床研究管理和 病人权益倡导。其他学科，如放射肿瘤学、病理学和免疫学 当临床试验在其主要目标中具有这些成分时，由成员在特别的基础上进行。

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.