Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 7438458
• 负责人: MIRIAM B BISCHOFF
• 金额: $ 14.9万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-04 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7438458
• 关键词: Awareness; California; Cancer Center; Cities; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Commit; Communities; Conduct Clinical Trials; Data Collection; Development; Documentation; Education; Funding; Goals; Growth; Hospitals; Malignant Neoplasms; Medical Research; Mission; Patient Care; Pediatric Hospitals; Performance; Process; Protocols documentation; Reporting; Research; Research Personnel; Resource Sharing; Resources; Services; Source; Standardization; Translational Research; anticancer research; data management; interdisciplinary collaboration; medical schools; outreach; performance site; programs; quality assurance

The Clinical Protocol and Data Management Shared Resource (known at Stanford as the "Cancer Clinical Trials Office" or CCTO) provides administrative, research, and educational services to Cancer Center investigators conducting clinical trials. The goals of the Clinical Protocol and Data Management Shared Resource are to: (1) Facilitate clinical trials and translational research by providing administrative support to all Cancer Center investigators; (2) Enhance and facilitate data collection and reporting of clinical cancer research; (3) Provide programs to contribute to quality assurance of performance and the ongoing education of Cancer Center Clinical Research Personnel; (4) Coordinate outreach efforts in the community (Northern California) to increase clinical trials awareness and accrual; and (5) Promote interdisciplinary collaborations and translational medical research. Prior to 2003, Stanford did not have an institutionally supported Cancer Clinical Trials Office. With the decision to apply for NCI-designation as a Cancer Center, the School of Medicine and Stanford Hospital committed funding to the development of a centralized Cancer Clinical Trials Office. The Facility Director was hired in June 2003. The funding for Fiscal Year 2004 was $750,000 allowing the hiring of a core staff of 6 FTE's. In Fiscal Year 2005, Lucile Packard Children's Hospital added its support to this effort. Funding from the three institutional sources totaled $1,400,000 allowing growth to 14 FTE's by August 2005. A small expansion is underway for FY 2006 with funding of $1,600,000 allowing growth to 15.5 FTE's. The CCTO organization has grown to meet the centralization, standardization, and reporting requirements of NCI-designation and the service needs of the clinical research staff. Each year services and usage have expanded. We will continue to adjust staffing and service offerings as needed to meet the priorities of the Cancer Center. PERFORMANCE SITE(S) (organization, city, state) Stanford UniverScientific Goals The mission of the Clinical Protocol and Data Management Shared Resource is to: 1. Facilitate clinical trials and translational research by providing centralized administrative support to all Cancer Center investigators. 2. Centralize and standardize data collection and reporting of clinical cancer research. 3. Provide programs to contribute to quality assurance of performance and the ongoing education of Cancer Center Clinical Research Personnel. 4. Coordinate outreach efforts in the community (Northern California) to increase clinical trials awareness and accrual. 5. Promote Interdisciplinary collaborations and translational medical research. The CCTO provides a centralized resource that assists clinical researchers with administrative services in order to facilitate protocol processing thus allowing the researcher to focus on scientific research needs and patient care. Programs of the Clinical Protocol and Data Management Shared Resource serve to increase awareness and accrual to clinical trials as well as to centralize and standardize the quality and efficiencies of conducting clinical trials in compliance with the regulatory, documentation, and oversight requirements. In this document the Protocol and Data Management Shared Resource will be referred to as the Cancer Clinical Trials Office (CCTO).sity, Stanford, CA PHS 398/2590 (Rev. 09/04) Page 847

临床协议和数据管理共享资源（在斯坦福大学被称为“癌症临床 临床试验办公室”或CTO）为癌症中心提供行政、研究和教育服务 进行临床试验的研究人员。临床方案和数据管理的目标共享 资源是： (1)通过向所有人提供行政支持，促进临床试验和转化研究 癌症中心研究人员; (2)加强和促进临床癌症研究的数据收集和报告; (3)提供有助于绩效质量保证和持续教育的计划 癌症中心临床研究人员; (4)协调社区（北方加州）的外展工作，以增加临床试验 认识和累积;以及 (5)促进跨学科合作和转化医学研究。 在2003年之前，斯坦福大学没有一个机构支持的癌症临床试验办公室。与 决定申请NCI-designation作为癌症中心，医学院和斯坦福大学医院 承诺资助发展一个集中的癌症临床试验办公室。该设施 主任于2003年6月受聘。2004财政年度的资金为750 000美元， 核心员工6人。在2005财政年度，露西尔·帕卡德儿童医院增加了对这一项目的支持。 努力来自三个机构来源的资金总额为140万美元， 2005年8月。2006财政年度正在进行一次小规模的扩张，资金为160万美元， 15.5 FTE的。 CTO组织已经发展到满足集中化、标准化和报告的要求 NCI认定的要求和临床研究人员的服务需求。每年服务 使用范围扩大了。我们会继续按需要调整人手和服务，以配合 癌症中心的优先事项。 履约地点（组织、城市、州） 斯坦福大学科学目标 临床方案和数据管理共享资源的使命是： 1.通过提供集中的行政管理，促进临床试验和转化研究 支持所有癌症中心的研究人员。 2.集中和标准化临床癌症研究的数据收集和报告。 3.提供计划，以促进性能和持续的质量保证 癌症中心临床研究人员的教育。 4.协调社区（北方加州）的外展工作，以增加临床试验 认识和积累。 5.促进跨学科合作和转化医学研究。 CTO提供了一个集中的资源，协助临床研究人员进行管理 服务，以促进协议处理，从而使研究人员专注于科学 研究需求和患者护理。临床方案和数据管理共享程序 资源用于提高临床试验的意识和收益，以及集中和标准化 按照法规进行临床试验的质量和效率， 文件和监督要求。 在本文件中，方案和数据管理共享资源将被称为 癌症临床试验办公室（CTO）.sity，斯坦福大学，CA PHS 398/2590（Rev. 09/04）第847页