Clinical Trials Reporting Program

临床试验共享资源(CTSR)对于在杜克综合癌症研究所内进行临床研究至关重要。在过去的20年里，这一资源已经从一个初期的一人礼宾办公室发展到现在的16名员工，集中管理礼仪开发、礼仪审查和监测系统(HRMS)管理、临床试验-质量保证和教育-项目r和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提供全方位服务的机构，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(礼仪管理、PRMS管理、礼仪电子研究数据库、患者登记、质量保证、安全监督台和CTSR工作人员的教育)都集中在一起。所有的DCCl议定书，无论是什么赞助，都通过CTSR办公室处理，供PRMS审查，并提取到中央数据库(电子研究)中。所有DCCI方案受试者都通过CTSR办公室和疾病地点集群注册，以便进入E-Research(基于过去五年的平均年总应计利润：5659名患者参加治疗试验；14420名受试者参加非治疗试验)。提供开办服务的人员也住在CTSR办公室。核心监测小组的工作人员是CTSR办公室的成员。临床试验操作被组织成由临床研究护士(CRN)和数据经理(CRA)组成的特定于疾病和模式的团队。目前的团队总人数超过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优先事项。CTSR主要由同行评审的DCCI成员使用，DCCI成员最优先考虑同行评审的研究。按存储容量使用计费的比例在不断变化，向进行同行评议研究的DCCl成员提供的折扣最大。

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.