Clinical Protocol and Data Management

临床方案和数据管理：总结/摘要 HDFCCC临床方案和数据管理（CPDM）的目标是支持和促进临床试验 在临床试验的整个生命周期中在HDFCCC中进行，包括方案制定、激活， 权责发生制和行为、监控、关闭和报告。临床方案制定和数据管理 HDFCCC的职能由临床研究支持办公室（CRSO）提供，该办公室提供 支持临床研究有效开发、实施、开展和报告的基础设施 研究，包括整个HDFCCC的临床研究人员的管理。CRSO还 整合和协调临床癌症研究活动与校园范围内的实体影响临床试验 行为，例如加州大学旧金山分校IRB和全校范围内的加州大学旧金山分校研究办公室。数据和安全监测 (DSM)职能，详见HDFCCC的NCI批准的数据和安全性监测计划（DSMP）， 由DSM工作人员执行，并由数据和安全监测委员会（DSMC）监督。在 除了进行数据和安全审查外，DSM活动还包括开发、维护和 研究者临床研究培训和临床研究培训的管理 人员，与CRSO合作进行。CPDM还促进了HDFCCC的承诺， 在临床研究中招募不同人群的患者，包括女性、少数民族和个体。 寿命HDFCCC努力确保其集水区的不同人口享有公平的 临床研究的获取、代表和受益。HDFCCC分析人口统计数据， 种族/民族、性别和年龄，以确定改善少数民族、妇女和个人包容性的领域 在临床研究的整个生命周期中。具体而言，CPDM（1）汇总了有关集水区的数据， HDFCCC和临床试验入组人口统计学，在疾病特异性水平;（2）分析这些数据， 了解所遇到的差异的潜在原因;（3）基于这些数据，与 调查人员、现场委员会和社区外展和参与（COE），以制定重点行动 计划;以及（4）定义和分析成功的指标，以评估解决这些差异的进展。

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.