Clinical Protocol and Data Management

Clinical Protocol and Data Management: Summary/Abstract The goal of HDFCCC Clinical Protocol and Data Management (CPDM) is to support and facilitate clinical trial conduct in the HDFCCC across the entire life cycle of a clinical trial, including protocol development, activation, accrual and conduct, monitoring, closure, and reporting. Clinical protocol development and data management functions in the HDFCCC are provided by the Clinical Research Support Office (CRSO), which provides the infrastructure to support the efficient development, implementation, conduct, and reporting of clinical research studies, including the management of clinical research personnel across the HDFCCC. The CRSO also integrates and coordinates clinical cancer research activities with campus-wide entities affecting clinical trial conduct, such as the UCSF IRB and the campus-wide UCSF Office of Research. Data and safety monitoring (DSM) functions, as detailed in the NCI-approved Data and Safety Monitoring Plan (DSMP) of the HDFCCC, are carried out by the DSM staff and overseen by the Data and Safety Monitoring Committee (DSMC). In addition to conducting data and safety review, DSM activities include the development, maintenance, and management of clinical research training for investigators and clinical research training for clinical research personnel, undertaken in collaboration with the CRSO. CPDM also facilitates the HDFCCC’s commitment to accrue diverse populations of patients on clinical studies, including women, minorities, and individuals across the lifespan. The HDFCCC strives to ensure that the diverse population of its catchment area has equitable access to, representation in, and benefit of clinical research. HDFCCC analyzes demographic data relating to race/ethnicity, gender, and age, to identify areas to improve inclusion of minorities, women, and individuals across the lifespan in clinical research. Specifically, the CPDM (1) aggregates data regarding catchment area, HDFCCC, and clinical trial enrollment demographics, at a disease-specific level; (2) analyzes these data to understand potential reasons for disparities that are encountered; (3) based on these data, works with investigators, site committees, and Community Outreach and Engagement (COE) to develop focused action plans; and (4) defines and analyzes metrics of success to evaluate progress in addressing these disparities.