The Clinical Research Unit (CRU) is critical to the conduct of clinical research at the Abramson Cancer Center (ACC). This core is a centralized administrative unit that coordinates protocol management, budget and financial analysis, regulatory affairs expertise, research nursing support, and data management for therapeutic clinical trials conducted by ACC investigators. The CRU supports peer-reviewed funded clinical research projects, invesfigator-initiated clinical trials, cooperative group trials, and industry-sponsored trials. All trials supported by the CRU are approved by the ACC Clinical Trials Scientific Review and Monitoring Committee and are subject to ACC Data and Safety Monitoring Committee internal audits. By providing the necessary infrastructure for the transfer of preclinical discoveries into the clinic, this core is central to the ACC mission to support translational research and high impact clinical trials. The availability of a senior scientific leader, who is an expert in clinical trials management, as well as highly skilled research personnel, allows ACC clinical invesfigators to develop and conduct a comprehensive range of clinical trials for all types of cancer that involve both novel agents and innovative treatment approaches. In response to the 2004 CCSG critique ofthe CRU, the ACC has implemented Velos eResearch, a clinical trials management system. This information system will improve efficiency of CRU operations and ensure data standardization and regulatory compliance. Additional changes in the clinical research infrastructure have enhanced the function of this core. These include the establishment of disease-specific research groups charged with the responsibility of managing their portfolio of clinical trials, based upon scienfific goals and available resources; the establishment ofthe Strategic Planning and Resource Committee, a centralized group that reviews a proposed protocol to be certain that adequate resources are available to support the trial and that the budget is appropriate. These additional reviews help assure that the resources ofthe CRU are focused on the highest priority clinical trials conducted by ACC members. From 1/2009 to 12/2009 49 new therapeutic clinical trials have been activated by the CRU. CCSG support represents 20% ofthe core's proposed budget with the remaining funding coming from other grants/contracts and institutional support.
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