The Markey Cancer Center (MCC ) Clinical Research and Data Management Shared Resource Facility (CRDM SRF ) coordinates and facilitates clinical cancer trials at the MCC . The major goals of this shared resource are to provide support of the clinical trial process, including implementing and regulating trials, provide a centralized clinical trial database, and integrate with the following: investigational pharmacy support, financial accounting, data safety monitoring, and quality assurance. This shared resource also assists physician investigators in the design and subsequent conduct of clinical trials through its support of the Investigator Initiated Trial Protocol Development Unit . It epidermis all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials. The CRDM SR F has Standard Operating Procedures for all its activities, including training of all new faculty and staff. From Ma y 2011 through April l 2012 , 2,542 new patients with cancer were seen at the MCC . Of these, 1,451 were from Appalachia n Kentucky . During this time period, the CRDM SR F administrate d therapeutic cancer clinical trials that engaged 253 (10% ) participants in therapeutic intent clinical trials. Importantly, 141 Appalachian patients were engaged in therapeutic intent clinical research, a 10 % accrual rate from this disadvantaged and unique population.
The CRD M SRF provides central management and oversight for coordinating , facilitating , and reporting on MCC cancer clinical trials . The CRDM SRF provides a central location for digital and hard copy cancer protocols, a central database of protocol-specific data , an updated list of active protocols for investigators an d protocol status reports . The CRDM SRF supports quality control functions, including education and training services for data managers and nurse and data auditing in support of the audit committee.
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