Clinical Trials Reporting Program

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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.