Clinical Protocol and Data Management (Core 017)

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CORE-017: CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) PROJECT SUMMARY / ABSTRACT The Clinical Protocol and Data Management (CPDM) function of the OSUCCC provides comprehensive resources for the conduct of cancer clinical research with an emphasis on the inclusion of women, minorities, children and other underserved populations. The CPDM is overseen by Dr. William Carson, the Associate Director for Clinical Research (ADCR). The cancer center's Clinical Trials Office (CTO), supports the centralized administration of protocol development, implementation and conduct for all clinically active cancer research groups. No clinical cancer research may be conducted outside the CTO. Thus, the CTO oversees all cancer clinical trials and is the centralized organization for the conduct of such research. This team provides the trial administration, protocol tracking and monitoring, data management, regulatory processing and financial supervision necessary for the successful conduct of clinical trials in a methodologically-sound, expedient, and cost-effective manner. The CTO Medical Director is Steven Devine, MD and the CTO Medical Co-Director is Dr. Bhuvana Ramaswamy, MD. The CTO interim Administrative Director is Nancy Single, PhD. The OSUCCC Data and Safety Monitoring Plan outlines the structure and responsibilities of the Data and Safety Monitoring Committee (DSMC) which oversees and reviews the safe conduct of clinical research at this cancer center. The DSMC is headed by William Blum, MD. The inclusion of women, minorities and children in cancer clinical research is an important goal of this organization and effort in this area are coordinated by the Center for Cancer Health Equity under the leadership of Electra Paskett, PhD, OSUCCC Associate Director for Population Sciences.