CORE--Protocol Review Monitoring System

CORE--协议审查监控系统

• 批准号: 6998304
• 负责人: KENNETH H. COWAN
• 金额: $ 2.18万
• 依托单位: UNIVERSITY OF NEBRASKA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-20 至 2009-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6998304
• 关键词: biomedical facility; clinical research; clinical trials; health science research support; neoplasm /cancer

DESCRIPTION (adapted from the application): All cancer-related protocols involving a UNMC faculty member or a UNMC Eppley Cancer Center member require review by the Scientific Review Committee. The mission of the Scientific Review Committee is complementary to that of the institutional Review Board (IRB). It does not duplicate or overlap the responsibilities of the IRB, which focuses on the protection of human subjects. The IRB will not issue a full approval for any cancerrelated study involving human subjects without first receiving notice of full approval from the Scientific Review Committee which attests that all scientific requirements for the study have been met. The Scientific Review Committee focuses on the scientific merit, prioritization, and progress of the research. The specific objective of the Scientific Review Committee include: ? Review scientific merit of cancer-related research involving human subjects at the UNMC Eppley Cancer Center. ? Foster development of innovative, collaborative, and scientifically sound studies which focus on the prevention, detection, diagnosis, and treatment of cancer including long-term follow-up and supportive care. ? Aid investigators in the establishment of the prioritization of studies and assure optimal allocation of the Cancer Center clinical and community resources. ? Assist investigators in the development and conduct of clinical cancer studies in conjunction with the Clinical Trials Office. ? Monitor progress of protocols relative to study objectives. ? Monitor accrual, data collection, and safety in conjunction with the Data Safety and Monitoring Committee and the Audit Committee. ? Provide a standard protocol format for submission and review.

描述(改编自申请)：涉及UNMC的所有癌症相关方案 教职员工或UNMC Eppley癌症中心成员需要由科学审查委员会审查。科学审查委员会的任务与机构审查委员会的任务相辅相成。它不与IRB的职责重复或重叠，IRB的重点是保护人类主体。在收到科学审查委员会的完全批准通知之前，IRB不会对任何涉及人类受试者的与癌症有关的研究发出全面批准，该委员会证明该研究的所有科学要求都已得到满足。科学审查委员会关注研究的科学价值、优先顺序和进展。科学审查委员会的具体目标包括： ？在UNMC审查涉及人类受试者的癌症相关研究的科学价值 埃普利癌症中心。 ？促进创新、协作和科学合理的研究的发展，这些研究侧重于癌症的预防、检测、诊断和治疗，包括长期随访和支持性护理。 ？协助调查人员确定研究的优先顺序，并确保最优 癌症中心临床和社区资源的分配。 ？协助研究人员共同开发和开展临床癌症研究 与临床试验办公室合作。 ？监控与研究目标相关的方案的进展。 ？与数据安全和监控一起监控应计、数据收集和安全 委员会和审计委员会。 ？提供用于提交和审查的标准协议格式。