CLINICAL PROTOCOL AND DATA MANAGEMENT: PROJECT SUMMARY/ABSTRACT Cancer clinical trials are a necessary and important part of the research activities at the Virginia Commonwealth University (VCU) Massey Cancer Center (MCC), as they provide the opportunity for cancer patients to receive the most promising new therapies and provide the mechanism that brings MCC laboratory findings into the clinic. Since its establishment in 1976, the Clinical Trials Office (CTO) has supported clinical cancer research at VCU. The CTO provides support for investigator-initiated trials (IITs), cooperative group trials as a MU-NCORP site and full member of Alliance, COG, ECOG-ACRIN and NRG Oncology, and corporate-sponsored studies, resulting in 184 accruals in 2015. The mission of the CTO is to provide central management and oversight for the coordination, facilitation, and support of the development and conduct of all oncology clinical research being conducted at the institution and its affiliated sites. The 52 CTO FTEs manage a portfolio of 184 clinical trials of which 149 are interventional and 35 non- interventional clinical research projects open to accrual, assuring the highest quality of research and adherence to relevant regulations by upfront coordination of the study and ongoing review of research compliance. The CTO provides 64 MCC clinical investigators support and study data management, as well as protocol development, regulatory affairs management, compliance responsibilities, quality assurance, and monitoring functions, screening for potential research participants, support of patient recruitment and treatment, coordination with pharmacy and other clinical services, record keeping, adverse event reporting, information dissemination and liaison with federal and industry sponsors and regulatory bodies. In addition, the CTO provides project management and development for MCC IITs, from concept development through activation, and ultimately, the reporting of results. The CTO provides resource support to the Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC), and the Cancer Clinical Research Committee (CCRC). The CTO has been active in NCI initiatives, to include the Clinical Trial Reporting Program (CTRP). The CTO has a track record of leading new endeavors for the research enterprise within VCU, as it supports the largest single clinical research group in the institution. The objectives of the CTO are to provide a well-trained, compassionate, ethical, and diverse clinical research staff that are supported by an integrated administrative organizational structure with efficient workflow processes within MCC, VCU Health, and the VCU Office of Research and Innovation. The CTO supports MCC clinical investigators in all aspects of conducting high quality clinical research to reduce the burden of cancer in the MCC catchment area, with an emphasis on minority and underserved populations.