Protocol Review & Monitoring System (PRMS)

方案审查

• 批准号: 9320507
• 负责人: Apar Kishor Ganti
• 金额: $ 6.3万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9320507
• 关键词: Amendment; Biometry; Cancer Center; Cancer Center Support Grant; Caring; Charge; Clinical Cancer Center; Clinical Oncology; Clinical Research; Clinical Sciences; Clinical Trials; Collection; Committee Members; Data; Detection; Development; Diagnosis; Disease; Enrollment; Faculty; Feasibility Studies; Feedback; Hematologic Neoplasms; Institutional Review Boards; Intervention Trial; Logistics; Malignant Neoplasms; Medical Oncology; Medical center; Modification; Monitor; Nebraska; Pathology; Patient Outcomes Assessments; Patients; Pediatric Oncology; Peer Review; Population; Population Sciences; Prevention; Principal Investigator; Process; Protocols documentation; Quality of life; Radiation Oncology; Recommendation; Regulation; Research; Research Activity; Research Personnel; Review Committee; Safety; Solid Neoplasm; Students; Suggestion; Supportive care; Surgical Oncology; System; Time; Universities; authority; base; behavioral study; cancer prevention; cancer therapy; falls; follow-up; human subject; innovation; member; multidisciplinary; oncology; screening; sound; survivorship; symptom management

Project Summary/Abstract: Protocol Review & Monitoring System The Fred and Pamela Buffett Cancer Center (FPBCC) has established a process by which proposed FPBCC clinical and population science protocols undergo internal peer review for scientific merit and prioritization prior to University of Nebraska Medical Center (UNMC) Institutional Review Board approval. Reviews by the FPBCC Scientific Review Committee (SRC) are to confirm the scientific validity of the proposed study, and to assess the feasibility of the study relative to the availability of human subjects and current protocols based on enrollments from that same patient and/or subject population. The FPBCC 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 (if warranted) to enhance the scientific merit and/or the logistics of the planned study. The FPBCC SRC is a multidisciplinary committee charged with overseeing the scientific aspects of cancer-related research involving human subjects conducted by UNMC students and faculty, including FPBCC 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 FPBCC SRC has the authority to approve, require modifications, or disapprove research activities that fall within its jurisdiction. FPBCC SRC members are selected to represent the broad spectrum of oncology research. The FPBCC SRC has broad expertise with representation from Medical Oncology, Surgical Oncology, Pediatric Oncology, Radiation Oncology, Pathology, and Biostatistics. The SRC has broad expertise in hematological malignancies and solid tumors, as well as in clinical research focused on supportive care and symptom management. Any Cancer Center member with expertise specific to a particular protocol may also be asked to serve as an ad hoc reviewer based on his/her unique qualifications when the relevant expertise is not available from SRC members.

项目概要/摘要：方案审查和监测系统 弗雷德和帕梅拉·巴菲特癌症中心（FPBCC）已经建立了一个程序， FPBCC临床和人口科学方案经过内部同行评审，以确定其科学价值， 内布拉斯加大学医学中心（UNMC）机构审查委员会批准之前的优先级。 FPBCC科学审查委员会（SRC）的审查旨在确认该方法的科学有效性 拟定的研究，并评估研究相对于人类受试者可用性的可行性， 当前方案基于来自相同患者和/或受试者人群的入组。FPBCC SRC 审查还确保拟定临床试验的数据和安全性监测计划是适当的， 根据法规，并向研究者提供反馈和建议（如有必要）， 增强计划研究的科学价值和/或后勤保障。FPBCC 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学生和教职员工，包括FPBCC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收集的干预性试验， SRC审查患者报告的结局。FPBCC 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。FPBCC SRC成员包括 选择代表肿瘤学研究的广泛范围。FPBCC SRC拥有广泛的专业知识， 来自内科肿瘤学、外科肿瘤学、儿科肿瘤学、放射肿瘤学、病理学、 和生物统计学。SRC在血液学恶性肿瘤和实体瘤方面具有广泛的专业知识， 临床研究侧重于支持性护理和症状管理。任何癌症中心成员， 也可要求特定方案的专门知识， 当SRC成员无法提供相关专业知识时，可提供独特的资格。