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）是杜克综合癌症研究所开展临床研究的关键。在过去的20年里，该资源已从一个最初的一人方案办公室发展到目前的16名工作人员，集中方案制定、方案审查和咨询系统（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个全方位的服务机构，为癌症研究所成员提供从开始到结束的临床试验服务。行政职能（方案管理、PRMS管理、方案的电子研究数据库、患者登记、质量保证、安全性监测台和CTSR工作人员的教育）都是集中的。所有DCCl方案，无论赞助商如何，都通过CTSR办公室进行处理，由PRMS进行审查，并提取到中央数据库（电子研究）中。所有DCCI方案受试者均通过CTSR办公室和疾病研究中心集群登记，以进入电子研究（基于过去五年的平均年总累积：5659例患者接受治疗性试验; 14，420例受试者接受非治疗性试验）。提供开办服务的人员也安置在技术和社会改革办公室。核心监测小组的工作人员是技术和社会改革办公室的成员。临床试验操作被组织成疾病和模式特定的临床研究护士（CRN）和数据管理员（CRA）团队。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计划保持一致。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优先事项。CTSR主要由同行评审的DCCI成员使用，最优先考虑同行评审的研究。退款是按比例滑动的，最大的折扣提供给DCCl成员进行同行评审的研究。