Clinical Protocol and Data Management

临床方案和数据管理 摘要 临床方案和数据管理/临床试验办公室(CPDM/CTO)提供集中和 开展成人癌症临床试验的综合基础设施和行政办公室 亨斯迈癌症研究所(HCI)的患者；CPDM/CTO与位于 儿童癌症研究初级儿童医院。CPDM/CTO已扩大，并 自2009年以来进行了重组，以反映癌症中心加强临床研究和 解决与临床试验相关的日益复杂的监管环境。CPDM/CTO 雇用96名员工，涉及研究协调、研究合规、数据管理、财务、监管、 标本处理和样本采集、研究护理、行政管理、方案撰写、资助 开发，以及向FDA提交研究用新药。CPDM/CTO实施的技术， 包括临床试验管理系统OnCore®，以高效、高效地管理临床 在HCI进行的研究。CPDM/CTO由临床研究执行委员会监督。 自2009年以来，CPDM/CTO修订、批准并实施了新的数据安全和监控 计划。数据和安全监控委员会(DSMC)确保由调查员发起的HCI 符合当地和联邦法规的临床试验，以及确保准确性、有效性和 研究数据的完整性。在HCI对所有类型的临床试验进行数据和安全监测， 包括生理毒性和剂量发现研究(第一阶段)、疗效研究(第二阶段)和有效性研究， 有效性和比较试验(第三阶段)。 HCI致力于为我们的集水区犹他州的所有居民提供服务，包括妇女， 儿童和得不到充分服务的少数群体，得到极好的护理和获得癌症治疗的最新进展 通过参与临床研究。为了实现这一目标，HCI遵循了NCI批准的计划 包括目标设定、外展和社区教育，以及促进/患者导航。到农村去 我们州的居民，以及犹他州的美洲原住民，有临床试验机会，HCI 与主要的临床护理公司InterMountain Healthcare建立并正式建立了研究伙伴关系 犹他州的供应商。亨斯迈-山间癌症护理计划的一个主要特点是同意 将两个组织的数据仓库与犹他州人口数据库互联，以支持临床 研究。通过此链接，85%可获得完整的诊断、治疗和结果信息 该州癌症患者获得批准的研究项目，增加了癌症研究的机会 多条战线。

CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT The Clinical Protocol and Data Management/Clinical Trials Office (CPDM/CTO) provides a centralized and comprehensive infrastructure and administrative office for the conduct of clinical trials involving adult cancer patients at Huntsman Cancer Institute (HCI); CPDM/CTO integrates with the Pediatric Trials Office located at Primary Children's Hospital for studies of cancers in children. The CPDM/CTO has been expanded and restructured since 2009, to reflect the Cancer Center's commitment to enhance clinical research and to address the increasingly complex regulatory environment associated with clinical trials. The CPDM/CTO employs 96 staff 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 CPDM/CTO implemented technologies, including the clinical trials management system, OnCore®, to efficiently and effectively manage clinical research conducted at HCI. The CPDM/CTO is supervised by the Clinical Research Executive Committee. Since 2009, CPDM/CTO has revised, approved, and implemented a new Data Safety and Monitoring plan. The Data and Safety Monitoring Committee (DSMC) ensures that HCI conducts investigator-initiated clinical trials in adherence with local and federal regulations, as well as ensuring the accuracy, validity, and integrity of the study data. Data and Safety Monitoring is conducted at HCI for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I), efficacy studies (Phase II), and efficacy, effectiveness, and comparative trials (Phase III). HCI is committed to serving all residents of our catchment area, the State of Utah, including women, children, and underserved minorities, with excellent care and access to the latest advances in cancer treatment through participation in clinical research. To achieve this goal, HCI has followed an NCI-approved plan that involves goal-setting, outreach and community education, and facilitation/patient navigation. To reach rural residents of our state, as well as Utah's Native American populations, with clinical trials opportunities, HCI developed and formalized a research partnership with Intermountain Healthcare, the major clinical care provider in Utah. A key feature of the Huntsman-Intermountain Cancer Care Program is the agreement to interlink the data warehouses for the two organizations with the Utah Population Database to support clinical research. Through this linkage, complete diagnosis, treatment, and outcomes information is available on 85% of cancer patients in the state for approved research projects, increasing opportunities for cancer research on many fronts.