Clinical Trials Office Shared Resource

临床试验办公室(CTO)提供集中和全面的基础设施，用于进行 亨斯迈癌症研究所(HCI)涉及癌症患者的临床试验。首席技术官已经演变成 自2003年以来大幅增加，以反映癌症中心对加强临床研究和 解决与临床试验相关的日益复杂的监管环境。首席技术官的职能是 一个中央行政办公室，负责实施和实施由内部和外部资助的成人 肿瘤学研究并与位于初级儿童医学中心的儿科试验办公室整合 用于研究儿童癌症。 CTO的目标是1)支持癌症中心研究人员制定方案的所有方面， 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、礼宾审查和监测系统的文件(已知 作为临床癌症调查委员会)，数据和安全监测委员会，食品和 药品管理局(FDA)和其他监管委员会，应联邦和犹他大学(U)的要求 U)政策；3)与研究赞助商和赞助的大学办公室谈判预算和合同 项目；4)管理研究资金的计费和收集；以及5)向监管机构提供高质量的数据 委员会和赞助商。 CTO在内部被组织为专门的职能：监管、财务和协调。这些团体 被指派支持与HCI多学科临床模型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。首席技术官目前雇佣了 35名工作人员和两名教员参与研究协调、研究合规、数据管理、财务、 规章制度、标本处理和样本采集、研究护理、管理、方案撰写、 授权开发，并向FDA提交研究新药备案。 CTO共享资源由肿瘤中心管理，由临床研究监督 执行委员会主席肖恩·马尔维希尔，医学博士，临床事务高级主任。 要求CCSG提供4%(109,171美元)的资金，以支付拟议的CTO份额 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.