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CORE--Protocol Review Monitoring System

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
依托单位国家:
美国
项目类别:
财政年份:
2004
资助国家:
美国
项目状态:
已结题
起止时间:
2004-09-20 至 2009-07-31

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中文摘要
翻译
描述(改编自应用程序):涉及UNMC的所有癌症相关方案 教师或UNMC Eppley癌症中心成员需要由科学审查委员会审查。科学审查委员会的使命是对机构审查委员会(IRB)的补充。它不会重复或重叠IRB的职责,IRB的重点是保护人类受试者。在未收到科学审查委员会的完全批准通知(证明研究符合所有科学要求)之前,IRB不会对涉及人类受试者的任何癌症相关研究发布完全批准。科学审查委员会侧重于研究的科学价值、优先顺序和进展。科学审查委员会的具体目标包括: ?在联合国医学委员会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,重点是预防,检测,诊断和治疗癌症,包括长期随访和支持性护理的发展。 ?帮助研究者确定研究的优先顺序,并确保最佳的 分配癌症中心的临床和社区资源。 ?协助研究者开发和开展临床癌症研究, 临床试验办公室 ?监测与研究目的相关的方案进展。 ?与数据安全性和监查部门一起监查招募、数据收集和安全性 委员会及审核委员会。 ?为提交和审查提供标准方案格式。
英文摘要
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.
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PAR04-122 Extramural Research Facilities Construction A*
ENVIRONMENTAL HEALTH INFORMATICS SYSTEM
GREAT PLAINS HEALTH INFORMATICS DATABASE
Protocol Specific Research
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