CLINICAL PROTOCOL AND DATA MANAGEMENT – PROJECT SUMMARY/ABSTRACT The Cancer Center has a vibrant and effective Clinical Protocol and Data Management infrastructure, composed of the following key elements: 1. An oversight committee, the Clinical Trials Advancement Committee (CTAC) 2. A central office, the Office for Clinical Research (OCR) 3. Disease-specific research teams 4. A Cancer Bioinformatics team 5. The Clinical Research Implementation Committee (CRIC) 6. Ancillary services including the Investigational Drug Services Pharmacy (IDS Pharmacy), Emily Couric Clinical Cancer Center (ECCCC) Nurse Liaison, and Biorepository and Tissue Research Facility (BTRF) 7. Cancer Center Clinical Research Orientation, Training, and Quality Assurance Program 8. Data and Safety Monitoring Plan (DSMP) and Data and Safety Monitoring Committee (DSMC) 9. Minority Recruitment Task Force (MRTF) Over the past five years, the Cancer Center has almost doubled accrual to therapeutic trials. The significant increase in accruals to treatment trials reflects the successful expansion and optimization of the clinical research infrastructure.