: The Markey Cancer Center (MCC ) Clinical l Research and Data a Management Shared Resource Facility (CRD M SRF ) coordinates and facilitates clinical cancer trials at the MCC . The major goals of the shared resource are to provide support of the clinical trial process , including implementing and regulating trials provide a centralized clinical trial l database , and integrate with the following: investigational pharmacy support , financial accounting , data safety monitoring , and quality assurance . This shared resource also assist s physician investigators in the design and subsequent conduct of clinical l trials through its support of the Investigator Initiated Trial Protocol Development Unit . It performs all regulatory reporting and quality assurance needed to comply with Good Clinical Practice in the performance of clinical trials . The CRDM SRF has Standard Operating Procedures for all its activities including training of all new faculty an d staff . From Ma y 2011 through April 2012 , 2,54 2 new patient s with cancer were seen at the MCC . Of these , 1,45 1 were from Appalachian Kentucky . During the s time period , the CRDM SRF administrated therapeutic cancer clinical l trials that engage d 25 3 (10% ) participants in therapeutic intent clinical trials . Importantly , 14 1 Appalachian patient s were engage d in therapeutic intent clinical research , a 10 % accrual rate from these disadvantaged and unique.

Public Health Relevance

The CRD M SR F provides central management an d oversight fo r coordinating , facilitating , and reporting on MCC cancer clinical trials . Th e CRDM SR F provides a central location for digital an d hard copy cancer protocols , a central database o f protocol-specific data , an update d lis t of active protocol s for investigators , an d protocol status reports . The CRDM SR F support s quality control functions , including education an d training service s for data managers and nurses and data auditing in support of the audit committee .

National Institute of Health (NIH)
Center Core Grants (P30)
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Subcommittee B - Comprehensiveness (NCI)
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University of Kentucky
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