Clinical Trials Office Shared Resource

临床试验办公室（CTO）为开展 亨斯迈癌症研究所（HCI）的癌症患者临床试验。首席技术官已经进化 自2003年以来，癌症中心一直致力于加强临床研究， 解决与临床试验相关的日益复杂的监管环境。CTO的职能是 中央行政办公室，负责实施和开展内部和外部资助的成人教育 肿瘤学研究并与位于小学儿童医学中心的儿科试验办公室整合 用于儿童癌症的研究。 CTO的目标是：1）支持癌症中心研究者制定方案的各个方面， 启动、实施、管理和临床研究协调; 2）准备和处理所有法规 提交给机构审查委员会、方案审查和监测系统（已知）的文件 HCI临床癌症研究委员会）、数据和安全监测委员会、食品和 根据联邦和犹他州大学（U 政策; 3）与研究赞助商和赞助商办公室协商预算和合同 项目; 4）管理研究资金的计费和收集;以及5）向监管机构提供优质数据 委员会和赞助商。 CTO在内部组织为专业职能部门：监管、财务和协调。这些群体 被分配用于支持与HCI多学科临床模型相匹配的特定器官肿瘤组。 一个具有独立报告结构的独立小组负责监督合规情况。CTO目前雇用 35名工作人员和两名教员参与研究协调、研究依从性、数据管理、财务， 法规、标本处理和样本采集、研究护理、管理、方案编写， 资助开发，并向FDA提交研究性新药申请。 CTO共享资源由癌症中心管理，并由临床研究部门监督 执行委员会由临床事务高级总监Sean Mulvihill（医学博士）担任主席。 请CCSG提供资金，用于支付拟议CTO分担费用的4%（109，171美元） 资源预算。

The Clinical Trials Office (CTO) provides a centralized and comprehensive infrastructure for the conduct of clinical trials involving cancer patients at Huntsman Cancer Institute (HCI). The CTO has evolved substantially since 2003 to reflect the Cancer Center's commitment to enhancing clinical research and to address the increasingly complex regulatory environment associated with clinical trials. The CTO functions as a central administrative office for the implementation and conduct of internally and externally funded adult oncology studies and integrates with the Pediatric Trials Office located at Primary Children's Medical Center for studies of cancers in children. The goals of the CTO are to 1) support Cancer Center investigators with all aspects of protocol development, initiation, implementation, management, and clinical study coordination; 2) prepare and process all regulatory documents for submission to the Institutional Review Board, Protocol Review and Monitoring System (known as the Clinical Cancer Investigations Committee at HCI), Data and Safety Monitoring Committee, Food and Drug Administration (FDA), and other regulatory committees, as required by federal and University of Utah (U of U) policies; 3) negotiate budgets and contracts with study sponsors and the U of U Office of Sponsored Projects; 4) manage billing and collection of study finances; and 5) provide quality data to regulatory committees and sponsors. The CTO is internally organized into specialty functions: regulatory, finance, and coordination. These groups are assigned to support specific organ-based tumor groups matching the HCI multidisciplinary clinical model. An independent group with a separate reporting structure oversees compliance. The CTO currently employs 35 staff and two faculty involved in study coordination, study compliance, data management, finance, regulation, specimen processing and collection of samples, research nursing, administration, protocol writing, grant development, and investigational new drug filing with the FDA. The CTO Shared Resource is managed by the Cancer Center with supervision by the Clinical Research Executive Committee chaired by Sean Mulvihill, MD, Senior Director of Clinical Affairs. The Funds are requested from the CCSG to cover 4 percent ($109,171) of the proposed CTO Shared Resource budget.