Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10712683
• 负责人: Charalambos Andreadis
• 金额: $ 106.46万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-05 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712683
• 关键词: Address; Affect; Age; Area; Cancer Center Support Grant; Catchment Area; Clinical; Clinical Data; Clinical Management; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Community Outreach; Conduct Clinical Trials; Data; Data Aggregation; Development; Disease; Disparity; Equity; Ethnic Origin; Gender; Goals; Individual; Infrastructure; Institutional Review Boards; Life Cycle Stages; Longevity; Maintenance; Malignant Neoplasms; Minority; Monitor; Patients; Population Heterogeneity; Race; Reporting; Research; Research Activity; Research Personnel; Research Priority; Research Support; Research Training; Safety; Site; Woman; Work; anticancer research; clinical training; clinical trial enrollment; community engagement; data management; demographics; improved; investigator training; patient population; protocol development; research study; success

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.

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 HDFCCC 中进行临床试验的整个生命周期，包括方案开发、激活、 权责发生制和实施、监测、结束和报告。 HDFCCC 的职能由临床研究支持办公室 (CRSO) 提供，该办公室提供 支持临床研究高效开发、实施、实施和报告的基础设施 研究，包括整个 HDFCCC 临床研究人员的管理。 与影响临床试验的校园范围内的实体整合和协调临床癌症研究活动 行为，例如 UCSF IRB 和整个校园的 UCSF 数据和安全监控办公室。 (DSM) 功能，详见 NCI 批准的 HDFCCC 数据和安全监测计划 (DSMP)， 由 DSM 工作人员执行并由数据和安全监测委员会 (DSMC) 监督。 除了进行数据和安全审查之外，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临床研究培训的管理 与 CRSO 合作进行的人员培训也促进了 HDFCCC 对以下方面的承诺： 在临床研究中积累不同的患者群体，包括女性、少数族裔和各个地区的个人 HDFCCC 努力确保其服务区域的不同人口享有公平的权利。 与 HDFCCC 相关的临床研究统计数据的获取、代表性和益处。 种族/民族、性别和年龄，以确定改善少数群体、妇女和个人包容性的领域 具体而言，CPDM (1) 汇总了有关服务区域的数据， HDFCCC 和特定疾病级别的临床试验注册人口统计数据； (3) 了解所遇到的差异的潜在原因； (3) 根据这些数据，与他人合作； 调查员、现场委员会和社区外展和参与 (COE) 制定有针对性的行动 计划；(4) 定义和汇总成功指标，以评估解决这些差异的进展情况。