PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT The Clinical Protocol and Data Management (CPDM) system at Sylvester Comprehensive Cancer Center (Sylvester) ensures patient safety, regulatory compliance, and data integrity in all clinical research. CPDM aligns Sylvester’s clinical research portfolio with the distribution of cancer throughout the catchment area (CA) in collaboration with the Sylvester Office of Outreach and Engagement (SOOE). Clinical Research Services (CRS) oversees CPDM to provide a centralized, high-quality, infrastructure to support investigators in developing, conducting, and reporting on clinical research with participant safety as the highest priority. The specific aims are 1) oversee and strengthen Sylvester’s clinical research infrastructure and operations to enable the conduct of clinical research trials in a timely and efficient manner; 2) provide investigators centralized, high-quality clinical study services, including staffing and administrative support for the development, activation, management, and reporting of clinical trials; 3) conduct quality assurance/quality control assessments and train clinical research staff and investigators to deliver best practices in conducting clinical studies and maintaining data accuracy and integrity; 4) ensure that all cancer research studies at Sylvester are conducted and monitored in strict compliance with institutional policies, the Sylvester Data Safety and Monitoring Plan (DSMP), and all state and federal regulations; and, 5) provide access to clinical studies for all cancer patients regardless of age, gender, race, ethnicity, or primary language and proactively identify and address barriers to study participation for individuals living in Sylvester’s CA. CRS supported 120 principal investigators (PIs), 87 of whom enrolled patients to interventional treatment studies during the current reporting period (6/1/2018-5/31/2023), the activation and completion of clinical protocols (293 active, enrolling protocols at the end of the reporting period), accurate reporting of data, 15 site disease groups and four clinical research teams, administration of research committees, and quality of all research. The Clinical Trials Coordination Unit (CTCU) is focused on operations and regulatory support. The Research Operations Support Unit (ROSU) facilitates administration of the Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Committee (DSMC). The Quality Management Unit (QMU) provides quality assurance, training for staff and investigators, and compliance with Sylvester’s DSMP. CRS uses the clinical trial management system, Velos eResearch, for participant, protocol, and monitoring requirements. During the reporting period, Sylvester supported 2,292 interventional treatment, 2,476 interventional non-treatment, and 12,655 non- interventional accruals reflecting the diversity and sociodemographic composition of the CA.