CLINICAL PROTOCOL AND DATA MANAGEMENT PROJECT SUMMARY/ABSTRACT The Clinical Protocol and Data Management Office, known at Yale University as the Yale Cancer Center (YCC) Clinical Trials Office (CTO), is the central management and operations organization for all clinical trials at YCC. Its primary goals are: 1) to facilitate efficient activation and conduct of therapeutic treatment trials in cancer across all disciplines at Yale;; and 2) to provide optimal infrastructure for the conduct of such trials, oversight of personnel through highest-level SOPs that ensure accurate conduct of protocol-mandated procedures and data capture, and full regulatory compliance with all trial aspects. We have made major progress in growing the CTO infrastructure to support increased treatment interventional (therapeutic) trial accrual, which has risen from 231 subjects in FY11 to over 800 in FY15, 16, and 17. This growth has included extending our services to 12 community-based Smilow Cancer Hospital clinics (Smilow Cancer Hospital Care Centers, or CCs) throughout Connecticut. This improvement has allowed us to provide seamless clinical trials access throughout the entire Smilow Cancer Hospital (SCH) network and has resulted in more than 130 accruals in FY16 and 17 from these sites. The CTO has grown from 40 to 120 employees over the last grant period, paralleling this increase in accrual. We have restructured the CTO since the last grant period to provide greater regulatory consistency and quality, and to provide more clinic-based data capture. In addition, we have emphasized Quality Assurance, with new recruits and new audit SOPs, as well as increased reporting to our Data Safety Monitoring Committee (DSMC). We also have focused on minority accrual through our outreach programs, including the widely recognized OWN-IT Project (Dr. Silber). We continue to grow and increase our clinical trials efforts to provide patients throughout Connecticut with the opportunity to participate in state-of- the-art clinical research.