Protocol Review and Monitoring System

方案审查和监控系统

• 批准号: 10491785
• 负责人: Apar Kishor Ganti
• 金额: $ 11.59万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-05 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10491785
• 关键词: Amendment; Biometry; Cancer Center; Cancer Center Support Grant; Caring; Charge; Clinical Cancer Center; Clinical Research; Clinical Sciences; Clinical Trials; Collection; Committee Members; Data; Detection; Development; Diagnosis; Discipline of Nursing; Disease; Enrollment; Ensure; Faculty; Feasibility Studies; Feedback; Hematologic Neoplasms; Institutional Review Boards; Intervention Trial; Lead; Logistics; Longterm Follow-up; Malignant Neoplasms; Medical Oncology; Medical center; Modification; Monitor; Nebraska; Oncology; Pathology; Patient Outcomes Assessments; Patients; Pediatric Oncology; Peer Review; Pharmacology; Population; Population Sciences; Prevention; Principal Investigator; Process; Protocols documentation; Quality of life; Radiation Oncology; Recommendation; Regulation; Research; Research Activity; Research Personnel; Review Committee; Safety; Site; Solid Neoplasm; Students; Suggestion; Supportive care; Surgical Oncology; System; Universities; authority; base; behavioral study; cancer prevention; cancer therapy; expedited review; falls; human subject; innovation; member; multidisciplinary; patient safety; screening; sound; survivorship; symptom management

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.

项目摘要：方案审查和监测系统 巴菲特癌症中心 (BCC) 建立了一个流程，通过该流程建议 BCC 临床和人群 科学研究协议在大学之前经过内部同行评审，以评估其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 成员进行。癌症预防研究， 筛选试验、行为研究、生活质量/生存研究和干预试验 患者报告结果的收集由 SRC 进行审查。 BCC SRC 有权批准、 要求修改或拒绝其管辖范围内的研究活动。 SRC 确认 拟议研究的科学有效性，并评估该研究相对于现有研究的可行性 人类受试者和基于同一患者和/或受试者的登记的正在进行的方案 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、符合规定的，并提供反馈和建议 研究者，以提高计划研究的科学价值和/或后勤工作。初步审查包括 分为两个阶段，首先是疾病重点小组 (DFT) 的初步审查和批准，然后是 通过SRC审查。经 NCI 批准的国家、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，接受快速审查，重点关注优先事项 和可行性。 BCC SRC 成员的选拔代表了广泛的肿瘤学研究。 BCC SRC 拥有广泛的专业知识，包括来自医学、外科、儿科和放射领域的代表 肿瘤学、药理学、病理学、护理学和生物统计学。该委员会还拥有广泛的专业知识 血液恶性肿瘤和实体瘤，以及支持治疗和症状的临床研究 管理。任何具有特定方案专业知识的癌症中心成员也可能会被要求 根据其独特的资格或在缺乏专业知识时担任普通评审员或临时评审员 来自 SRC 成员。