Clinical Protocol and Data Management Summary The Masonic Cancer Center (MCC) provides comprehensive and integrated resources to help cancer researchers develop and conduct interventional clinical trials, including translational development, clinical research services, regulatory support, protocol development, and trial management and monitoring. The MCC Clinical Trials Office (CTO) was established in 2001 to enhance MCC members’ ability to conduct clinical cancer research. It assists investigators in developing, activating, and completing scientifically meritorious clinical trials in a high-quality, cost-effective, and efficient manner. At the same time, the CTO ensures the validity and integrity of data to fulfill all NCI, federal, and local regulatory requirements, through the aims of 1) delivering high-quality support services to facilitate efficient implementation and conduct of clinical trials for all Cancer Center investigators, 2) continually implementing strategies to improve trial activation timelines and effectively engage disease-specific teams to monitor the performance of the clinical trial portfolio to optimize accrual, and 3) ensuring continued and expanded access to clinical trials within the community by optimizing a centralized infrastructure to meet the needs of our diverse population and support community partnerships across Minnesota and beyond. The CTO is led by Associate Director for Clinical Research (AD) Melissa Geller, MD, MS (Transplant and Cellular Therapy Program), and Executive Director of Clinical Research, Dedra Schendzielos, MHA, who provide senior leadership and operations oversight. Dr. Geller was appointed AD in January 2022 to transform the CTO to serve growing faculty interest in complex early-phase clinical trials. Ms. Schendzielos began her position in June 2021. Over the past 5 years, there were 563 active clinical trials using CTO services, 219 of which were investigator-initiated. During the pandemic, the CTO pivoted to work toward a more equitable, accessible, and efficient clinical research process. We developed strategies to minimize burdens on research sites and participants. Many aspects of clinical research evolved to using electronic tools, including remote signing of research documents and telehealth clinical encounters. From March 2020 to March 2022, we adapted our protocols and procedures to ensure safe and continual recruitment, and the initiation of remote work options stabilized staff turnover, with a 47% decrease in departures. The CTO has added new staff roles and additional staff to existing roles to support the growth in complex clinical trials. It also successfully implemented a new Developmental Therapeutics Initiative (DTI) focused on expanded access to early-phase clinical trials and on the translational aspects of this research. Over the next 5 years, we will focus our efforts on building out the DTI. We have resources dedicated to hire a program nurse lead for the DTI and have ins...