ABSTRACT, Clinical Protocol and Data Management (CPDM) The Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) provides the clinical research infrastructure to support IUSCCC investigators and enhance their clinical research productivity. The CTO provides comprehensive services to assist investigators in developing, activating, and conducting scientifically meritorious cancer clinical trials, recruits and trains research staff, and educates clinical investigators. At the same time, the CTO ensures the validity and integrity of data to fulfill all National Cancer Institute (NCI), federal, and local regulatory requirements and coordinates activities with the Protocol Review Management System, Data and Safety Monitoring Committee, IUSCCC Compliance Office, Institutional Review Board (IRB), disease-oriented teams, and protocol sponsors. The Compliance Office reports directly to the Associate Director for Clinical Research and monitors and audits all IUSCCC investigator-initiated trials (IITs) to ensure subject safety, scientific validity, and data integrity. We accomplish these goals through the following Specific Aims: Aim 1: 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: Expand access to clinical trials, particularly for underserved populations, to better reflect and serve our catchment area while reducing the time to study completion; and Aim 3: Maintain regulatory compliance, subject safety, and data quality to instill confidence in clinical trial participation and results. Over the past funding cycle, the CTO staff has grown by 32% to support the growth and increased complexity of clinical research at IUSCCC. We have invested in multiple organizational improvements, including expanding the multi-center team and patient-facing non-licensed clinical research staff, increasing protocol development services, and adding a Statewide Oncology Research Administrator. While accrual over the entire current grant period decreased due to the COVID-19 pandemic, interventional accruals recovered and exceeded pre-pandemic levels in 2022 (1484 vs. 1370 in 2019). Our commitment to therapeutic IITs led to a 27% increase in IIT accrual for the current grant period (2018-22) over the prior (2013-17) grant period.