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）提供集中的 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已扩展， 自2009年以来进行了重组，以反映癌症中心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。CPDM/CTO 雇用了96名工作人员，参与研究协调、研究依从性、数据管理、财务、法规， 样本处理和样本收集，研究护理，管理，方案编写，资助 开发，以及向FDA提交的研究性新药。CPDM/CTO实施技术， 包括临床试验管理系统OnCore®，以高效管理临床试验 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测 计划数据和安全性监测委员会（DSMC）确保HCI进行验证者发起的 临床试验遵守当地和联邦法规，并确保准确性，有效性， 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性监测， 包括生理毒性和剂量探索研究（I期）、疗效研究（II期）和疗效， 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，包括妇女， 儿童和得不到充分服务的少数民族，得到良好的照顾，并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， 涉及目标设定、外展和社区教育以及便利/患者导航。为了达到农村 我们州的居民，以及犹他州的美洲原住民，有临床试验的机会，HCI 开发并正式与Intermountain Healthcare建立了研究合作伙伴关系，Intermountain Healthcare是主要的临床护理机构， 提供商在犹他州。Huntsman-Intermountain癌症护理计划的一个关键特征是， 将两个组织的数据仓库与犹他州人口数据库互连，以支持临床 research.通过这种联系，85%的患者可以获得完整的诊断、治疗和结局信息。 癌症患者在国家批准的研究项目，增加癌症研究的机会， 很多战线。

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.