Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 8853749
• 负责人: Wallace Lovell Akerley
• 金额: $ 16.41万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-05-09 至 2020-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8853749
• 关键词: Abbreviations; Access to Information; Address; Adherence; Adult; Agreement; American Indians; Cancer Center; Cancer Center Support Grant; Cancer Patient; Catchment Area; Certification; Child; Childhood; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Community Health Education; Complex; Conduct Clinical Trials; Data; Development; Diagnosis; Dose; Ensure; Environment; Gender; Goals; Grant; Health Services Accessibility; Healthcare; Home environment; Industry; Institutes; Investigational Drugs; Leadership; Malignant Neoplasms; Minority; Minority Groups; Mission; Monitor; Native Americans; Nursing Administration Research; Outcome; Patients; Pediatric Hospitals; Phase; Physiological; Population; Population Database; Process; Protocols documentation; Provider; Qualifying; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Project Grants; Rest; Role; Rural; Safety; Sampling; Specimen Handling; System; Technology; Toxic effect; Treatment outcome; Underrepresented Minority; Utah; Woman; Writing; abstracting; acronyms; anticancer research; cancer care; cancer therapy; career; clinical care; comparative trial; data management; effectiveness trial; efficacy trial; improved; operation; outreach; phase 1 study; phase 2 study; programs; sample collection; skills

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.

临床方案和数据管理 抽象的 临床方案和数据管理/临床试验办公室 (CPDM/CTO) 提供集中和 进行成人癌症临床试验的综合基础设施和行政办公室 亨斯曼癌症研究所 (HCI) 的患者； CPDM/CTO 与位于以下位置的儿科试验办公室整合 初级儿童医院研究儿童癌症。 CPDM/CTO 已扩大并 自 2009 年以来进行了重组，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。 CPDM/CTO 雇用 96 名员工，负责研究协调、研究合规、数据管理、财务、监管、 样本处理和样本采集、研究护理、行政管理、方案撰写、资助 开发以及向 FDA 提交研究性新药申请。 CPDM/CTO 实施的技术， 包括临床试验管理系统OnCore®，以高效、有效地管理临床试验 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控 计划。数据和安全监测委员会 (DSMC) 确保 HCI 进行研究者发起的 临床试验遵守当地和联邦法规，并确保准确性、有效性和 研究数据的完整性。 HCI 对所有类型的临床试验进行数据和安全监控， 包括生理毒性和剂量探索研究（第一阶段）、功效研究（第二阶段）和功效， 有效性和比较试验（第三阶段）。 HCI 致力于为我们辖区犹他州的所有居民提供服务，包括女性、 儿童和服务不足的少数族裔获得优质护理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。到达农村 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 与主要临床护理机构 Intermountain Healthcare 建立并正式建立了研究合作伙伴关系 犹他州的提供商。亨斯迈山间癌症护理计划的一个重要特点是同意 将两个组织的数据仓库与犹他州人口数据库互连，以支持临床 研究。通过这种联系，85% 的患者可以获得完整的诊断、治疗和结果信息 该州的癌症患者获得批准的研究项目，增加了癌症研究的机会 许多战线。