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：协议审查和监视系统 巴菲特癌症中心（BCC）建立了一个过程，该过程提出了BCC临床和人群 科学研究方案接受了大学之前的科学功绩和优先级的内部同行评审 内布拉斯加州医疗中心（UNMC）机构审查委员会的批准。 BCC SRC是多学科 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教师和学生以及BCC成员的成员进行。癌症预防研究， 筛查试验，行为研究，生活质量 /生存研究以及依赖的介入试验 SRC审查了患者报告的结果的收集。 BCC SRC有权批准， 需要修改或不赞成属于其管辖范围内的研究活动。 SRC确认 拟议研究的科学有效性，并评估研究相对于可用性的可行性 基于同一或患者和/或受试者的注册人的人类受试者和正在进行的协议 人口。 BCC SRC审查还确保了拟议的数据和安全监控计划 临床试验是适当的，并且符合法规，并提供反馈和建议 研究人员，以增强计划研究的科学功绩和/或后勤工作。最初的评论包括 两个阶段，首先是以疾病为中心的小组（DFT）的初步审查和批准 由SRC评论。国家，外部同行审查和多机构研究和批准的NCI 指定或全面的中心为领先地点，收到了快速审查，重点是优先级 和可行性。选择BCC SRC成员来代表广泛的肿瘤学研究。 BCC SRC具有广泛的专业知识，并具有医疗，外科，小儿和辐射的代表 肿瘤学，药理学，病理学，护理和生物统计学。该委员会还拥有广泛的专业知识 血液学恶性肿瘤和实体瘤以及支持性护理和症状的临床研究 管理。任何具有特定特定协议专业知识的癌症中心成员也可以被要求 根据他们的独特资格或没有专业知识，作为一般或临时审阅者 来自SRC成员。