Protocol Review and Monitoring System

项目摘要：方案审查和监测系统 巴菲特癌症中心（BCC）已经建立了一个过程，提出BCC的临床和人口 科学研究方案在大学之前进行内部同行评审，以确定科学价值和优先顺序 内布拉斯加州医学中心（UNMC）机构审查委员会批准。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的教师和学生以及BCC成员进行。癌症预防研究， 筛查试验、行为研究、生活质量/生存率研究和依赖于 SRC审查患者报告结局的收集。BCC SRC有权批准， 要求修改或不批准属于其管辖范围的研究活动。SRC证实， 拟议研究的科学有效性，并评估研究相对于可用性的可行性， 人类受试者和基于来自相同或患者和/或受试者登记的正在进行的方案 人口BCC SRC审查还确保拟定的数据和安全性监测计划 临床试验是适当的，符合法规，并提供反馈和建议， 研究者，以增强计划研究的科学价值和/或后勤。初步审查包括 两个阶段，首先是疾病重点小组（DFTs）的初步审查和批准， SRC的评论。经批准的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研究中心，接受快速审查，重点是优先级 和可行性BCC SRC成员被选为代表广泛的肿瘤学研究。 BCC SRC拥有广泛的专业知识，代表来自医疗，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门知识： 血液恶性肿瘤和实体瘤，以及支持性护理和症状临床研究 管理任何具有特定方案专业知识的癌症中心成员也可能被要求 根据其独特的资格或在专业知识不可用时，担任一般或临时审查员 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.