Clinical Trials Reporting Program

临床试验报告计划

• 批准号: 8753448
• 负责人: Michael B Kastan
• 金额: $ 1.87万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8753448
• 关键词: Archives; Back; Breast; Cancer Patient; Charge; Clinical Nursing Research; Clinical Research; Clinical Trials; Conflict of Interest; Data; Data Reporting; Databases; Devices; Diagnostic and Statistical Manual; Disease; Disorder by Site; Education; Electronics; Embryo; Enrollment; Ensure; Funding; Goals; Grant; Housing; Human Resources; Immunobiology; Information Systems; Institutes; Institutional Review Boards; Malignant Neoplasms; Modality; Monitor; Ovarian; Patients; Peer Review; Persons; Process; Protocols documentation; Randomized; Reporting; Research; Research Peer Review; Research Personnel; Resource Sharing; Resources; Safety; Services; Site Visit; Slide; Structure; System; Therapeutic; Therapeutic Agents; Therapy Clinical Trials; Time; United States National Institutes of Health; Update; Work; abstracting; base; discount; member; oncology; operation; programs; protocol development; quality assurance; Archives; Back; Breast; Cancer Patient; Charge; Clinical Nursing Research; Clinical Research; Clinical Trials; Conflict of Interest; Data; Data Reporting; Databases; Devices; Diagnostic and Statistical Manual; Disease; Disorder by Site; Education; Electronics; Embryo; Enrollment; Ensure; Funding; Goals; Grant; Housing; Human Resources; Immunobiology; Information Systems; Institutes; Institutional Review Boards; Malignant Neoplasms; Modality; Monitor; Ovarian; Patients; Peer Review; Persons; Process; Protocols documentation; Randomized; Reporting; Research; Research Peer Review; Research Personnel; Resource Sharing; Resources; Safety; Services; Site Visit; Slide; Structure; System; Therapeutic; Therapeutic Agents; Therapy Clinical Trials; Time; United States National Institutes of Health; Update; Work; abstracting; base; discount; member; oncology; operation; programs; protocol development; quality assurance

The Clinical Trials Shared Resource (CTSR) is pivotal to the conduct of clinical research within the Duke Comprehensive Cancer Institute. This resource has evolved over the past 20 years from an embryonic one person protocol office to Its current staff of 16, centralizing protocol development, Protocol Review and Monitoring-System-(HRMS)-administration,-the Clinical-Trials-Quality-Assurance-and -Education-Program r and the Duke Comprehensive Cancer Institute (DCCI) Clinical Trials Office. The DCCI Clinical Trials Office Is a full-service operation offering start-to-finish clinical trials services to Cancer Institute members. The administrative functions (protocol administration, PRMS administration, E-research database of protocols, patient registration, quality assurance, safety surveillance desk and education of the CTSR staff) are all centralized. All DCCl protocols, regardless of sponsorship, are processed through the CTSR Office for review by the PRMS and abstracted into the central database (E-research). All DCCI protocol subjects are registered through the CTSR Office and the disease site clusters for entry in E-research (average annual total accrual based on last five years: 5659 patients on therapeutic trials; 14,420 subjects on non-therapeutic trials). Personnel providing start-up services are also housed in the CTSR Office. The Core Monitoring Team is staffed by members of the CTSR Office. Clinical trials operations are organized into disease and modality specific teams of Clinical Research Nurses (CRNs) and data managers (CRAs). The current teams, with total staffing over 100, are aligned with the existing programs of Breast and Ovarian Oncology, Experimental Therapeutics, Cancer Immunobiology, and Radiafion Oncology. The goal of the CTSR is to align its services in support ofthe scientific priorities ofthe Duke Comprehensive Cancer Institute. The CTSR is used mostly by peer-reviewed, DCCI members with highest priority given to peer-reviewed research. Charge-backs are on a sliding scale, with the biggest discounts provided to DCCl members conducting peer-reviewed research.

临床试验共享资源（CTSR）对于杜克综合癌症研究所内的临床研究至关重要。在过去的20年中，该资源从胚胎一个人协议办公室发展到目前的16名员工，集中协议开发，协议审查和监测系统 - （HRMS） - 管理 - 管理， - 临床 - 质量 - 质量 - 质量 - 质量和 - 教育计划R和-DUKE综合癌症研究所（DCCI）临床试验办公室。 DCCI临床试验办公室是一项全方位服务的操作，为癌症研究所成员提供开始到本次的临床试验服务。行政职能（协议管理，PRMS管理，E-Research数据库，协议数据库，患者注册，质量保证，安全监视台和CTSR员工的教育）都是集中的。所有DCCL协议，无论赞助如何，都通过CTSR办公室进行处理，以供PRMS进行审查，并将其抽象为中央数据库（E-Research）。所有DCCI方案受试者均通过CTSR办公室和疾病现场群集进行注册，以进行电子研究（基于过去五年的平均年度总应计：5659例治疗试验患者；非治疗试验的1420名受试者）。提供启动服务的人员也位于CTSR办公室。核心监测团队由CTSR办公室成员组成。临床试验操作被组织为疾病和模态特定于临床研究护士（CRN）和数据经理（CRA）的团队。目前的团队总数超过100个，与现有的乳房和卵巢肿瘤学，实验性治疗，癌症免疫生物学和避热性肿瘤学的计划保持一致。 CTSR的目标是使其服务保持一致，以支持杜克综合癌症研究所的科学重点。 CTSR主要由同行评审的DCCI成员使用，其优先级为同行评审研究。抵押贷款的范围为滑动规模，向DCCL成员提供了同行评审研究的最大折扣。