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

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开展临床研究至关重要。在过去的 20 年里，这一资源已从最初的单人方案办公室发展到目前由 16 名员工组成，集中管理方案开发、方案审查和监测系统 (HRMS) 管理、临床试验质量保证和教育计划以及杜克综合癌症研究所 (DCCI) 临床试验办公室。 DCCI 临床试验办公室是一家全方位服务机构，为癌症研究所成员提供从始至终的临床试验服务。管理功能（方案管理、PRMS 管理、方案电子研究数据库、患者登记、质量保证、安全监控台和 CTSR 工作人员的教育）都是集中化的。所有 DCCl 方案，无论赞助情况如何，均通过 CTSR 办公室进行处理，供 PRMS 审查并抽象到中央数据库（电子研究）中。所有 DCCI 方案受试者均通过 CTSR 办公室和疾病中心集群进行注册，以便进入电子研究（基于过去五年的平均年度总应计：5659 名患者参加治疗试验；14,420 名受试者参加非治疗试验）。 CTSR办公室还设有提供启动服务的人员。核心监测小组由 CTSR 办公室成员组成。临床试验操作由临床研究护士 (CRN) 和数据管理员 (CRA) 组成的疾病和模式特定团队组成。目前的团队总人员超过 100 人，与乳腺和卵巢肿瘤学、实验治疗学、癌症免疫生物学和放射肿瘤学的现有项目保持一致。 CTSR 的目标是调整其服务以支持杜克综合癌症研究所的科学重点。 CTSR 主要由经过同行评审的 DCCI 成员使用，其中同行评审研究具有最高优先级。退款按浮动比例进行，为进行同行评审研究的 DCCl 成员提供最大折扣。