ABSTRACT, Clinical Protocol and Data Management (CPDM) The CTO is critical to the success of all clinical trials conducted through the IUSCC. In 2017, the CTO managed 367 active trials, 101 of which were Investigator Initiated (IITs). The CTO is led by Associate Director for Clinical Research, Kathy Miller, M.D. (EDT) and Administrator, Mario Contreraz, MBA, MSN, RN, CCRC, who provide leadership and oversight of the day-to-day operations to ensure comprehensive high-quality services and to streamline efforts to open trials and increase accrual. The Indiana University Melvin and Bren Simon Cancer Center (IUSCC) Clinical Trials Office (CTO) supports and enhances IUSCC members' ability to conduct clinical cancer research. The CTO provides comprehensive services to assist investigators in developing, activating and completing scientifically meritorious clinical trials in a high quality, cost-effective, efficient manner. At the same time, the CTO ensures the validity and integrity of data in order to fulfill all NCI, federal and local regulatory requirements. The CTO does so, through the following Specific Aims: Aim 1: To facilitate the efficient development, conduct, and reporting of clinical trials across the range of therapeutic interventional, correlative and population-based studies by maintaining a centralized infrastructure and educated workforce; Aim 2: To ensure continued and expanded access to clinical trials, particularly for the underserved populations within our catchment area and beyond.; and Aim 3: To support clinical trial accrual through the implementation and coordination of disease-oriented teams (DOTs). Over the past funding cycle, we have created new positions to better support the increasing clinical trial complexity driven by the increase in IITs and IUSCC-led multicenter trials. For example, we hired multicenter coordinators (MCRC) to support continued growth of our investigator-initiated multi-center trials and a second protocol development specialist to assist with IITs. The CTO has also created positions for Clinical Research Protocol Specialists (CRPS), who aid in the conduct and management of non-interventional correlative trials including subject consent, verification of eligibility, collection and submission of key clinical and laboratory data elements.