Protocol Review and Monitoring System

项目总结：议定书审查和监测系统 巴菲特癌症中心(BCC)已经建立了一个流程，通过该流程建议BCC临床和人口 科学研究方案在大学之前接受内部同行评审，以确定科学价值和优先顺序 内布拉斯加州医疗中心(UNMC)机构审查委员会的批准。BCC SRC是一个多学科的 负责监督涉及人类受试者的癌症相关研究的科学方面的委员会 由UNMC教职员工和学生以及BCC成员主持。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 SRC审查患者报告的结果的收集。BCC SRC有权批准， 要求修改，或不批准其管辖范围内的研究活动。SRC确认 拟议研究的科学有效性，并评估研究的可行性相对于可获得性 基于来自相同或患者和/或受试者登记的人类受试者和正在进行的方案 人口。BCC SRC审查还确保拟议的数据和安全监测计划 临床试验是适当的，并符合规定，并向 研究人员，以提高计划研究的科学价值和/或后勤保障。初步审查包括 两个阶段，首先由疾病重点小组(DFT)进行初步审查和批准 由SRC审查。具有批准的NCI的国家、外部同行评审和多机构研究 指定或综合中心作为牵头地点，接受了快速审查，重点是优先级 和可行性。BCC SRC成员被选为代表肿瘤学研究的广泛领域。 BCC SRC拥有广泛的专业知识，其代表来自内科、外科、儿科和放射科 肿瘤学、药理学、病理学、护理学和生物统计学。委员会还在以下方面拥有广泛的专业知识 恶性血液病和实体肿瘤，以及支持性护理和症状的临床研究 管理层。任何具有特定方案专业知识的癌症中心成员也可被要求 根据他们的独特资质或在没有专业知识的情况下担任普通审查员或临时审查员 来自SRC成员。

PROJECT SUMMARY: PROTOCOL REVIEW AND MONITORING SYSTEM The Buffett Cancer Center (BCC) has established a process by which proposed BCC clinical and population science research protocols undergo internal peer review for scientific merit and prioritization prior to University of Nebraska Medical Center (UNMC) Institutional Review Board approval. The BCC SRC is a multidisciplinary committee charged with overseeing the scientific aspects of cancer-related research involving human subjects conducted by members of the UNMC faculty and students, and BCC Members. Cancer prevention studies, screening trials, behavioral studies, quality of life / survivorship studies, and interventional trials that rely on collection of patient-reported outcomes are reviewed by the SRC. The BCC SRC has the authority to approve, require modifications, or disapprove research activities that fall within its jurisdiction. The SRC confirms the scientific validity of the proposed study, and assesses the feasibility of the study relative to the availability of human subjects and ongoing protocols based on enrollments from that same or patient and/or subject population. The BCC SRC review also assures that the data and safety monitoring plan for the proposed clinical trial is appropriate and in accordance with regulations, and provides feedback and recommendations to the investigator, to enhance the scientific merit and/or the logistics of the planned study. Initial review includes two stages, beginning with preliminary review and approval by the Disease Focused Teams (DFTs) followed by the SRC review. National, Externally Peer Reviewed and Multi-Institutional studies with an approved NCI Designated or Comprehensive Center as the lead site, received expedited review, which focuses on priority and feasibility. The BCC SRC members are selected to represent the broad spectrum of oncology research. The BCC SRC has broad expertise with representation from Medical, Surgical, Pediatric and Radiation Oncology, Pharmacology, Pathology, Nursing and Biostatistics. The Committee also has broad expertise in hematological malignancies and solid tumors, as well as in clinical research in supportive care and symptom management. Any Cancer Center member with expertise specific to a particular protocol may also be asked to serve as an at-large or ad-hoc reviewer based on their unique qualifications or when expertise is not available from SRC members.