CLINICAL TRIALS SUPPORT OFFICE

临床试验支持办公室(CTSO)成立于2002年，旨在为临床试验提供支持 三弗雷德·哈钦森/华盛顿大学癌症联盟(Consortium)的研究人员 华盛顿大学弗雷德·哈钦森癌症研究中心(FHCRC) (UW)，以及儿童医院和地区医疗中心(儿童)。的首要目标是 CTSO将提供基础设施，以支持进行高效、高质量、合规的 该联盟内的临床试验。为此，CTSO提供了集中的 对癌症联盟成员和研究人员进行适当行为的培训和教育 临床试验。CTSO还以按服务收费的方式提供研究人员，以实施 并管理临床试验的所有方面。CTSO负责临床试验的监测 计划和特定于议定书的研究支持活动。 CTSO的主要职能是：1)提供经验丰富、知识渊博的工作人员，以促进 由联盟研究人员实施和管理临床试验。2)提供培训 向调查人员和研究人员提供适当执行和管理的服务 临床试验。3)按照NCI批准的财团的要求对正在进行的临床试验进行监测 数据安全和监控计划。4)提供专业知识、人员和行政管理 支持联合体内临床试验计划的初步开发，特别是 强调年轻的调查人员和具有战略针对性的领域。5)优化资源，以 最大限度地提高临床试验的成本效益管理。

The Clinical Trials Support Office (CTSO) was established in 2002 to provide support for clinical researchers at the three Fred Hutchinson/University of Washington Cancer Consortium (Consortium) institutions, which are Fred Hutchinson Cancer Research Center (FHCRC), University of Washington (UW), and Children's Hospital and Regional Medical Center (Children's). The overarching goal of the CTSO is to provide the infrastructure to support the conduct of efficient, high-quality, regulatorycompliant clinical trials within the Consortium. Toward this end, the CTSO provides centralized training and education to Cancer Consortium members and research staff on appropriate conduct of clinical trials. The CTSO also provides, on a fee-for-service basis, research study staff to implement and manage all aspects of clinical trials. The CTSO is responsible for the clinical trials monitoring program and for Protocol-Specific Research Support activities. The key functions of the CTSO are to: 1) Provide experienced, knowledgeable staff to facilitate the implementation and management of clinical trials by Consortium investigators. 2) Provide training services to investigators and research staff in the appropriate implementation and management of clinical trials. 3) Conduct monitoring of ongoing clinical trials as mandated by the Consortium NCIapproved data safety and monitoring plan. 4) Provide expertise, personnel and administrative support for initial development of clinical trials programs within the Consortium, with a special emphasis on young investigators and strategically targeted areas. 5) Optimize resources to maximize cost-effective management of clinical trials.