Clinical Protocol and Data Management

项目摘要/摘要(临床方案和数据管理) 癌症中心支持授予临床和方案数据管理(CPDM)要求 密歇根大学罗杰尔癌症中心是通过肿瘤学临床试验支持单位完成的 (O-CTSU)。禁毒办在项目期间发展和加强了其努力，加强了 密歇根大学癌症临床试验的有效性、效率和总体支持。 O-CTSU协助调查人员创建、提交、审查、激活、ct.gov登记、进行、 对创新的癌症临床试验进行有效、合规的监督和收尾报告 科学合理的态度。通过提供全面的集中服务，包括协调器 工作人员、标准化政策和程序、培训和教育、信息学和标本处理 O-CTSU有助于确保为所有癌症临床试验提供高效和有效的支持。在最近的一段时间里， O-CTSU对临床研究的支持进行了重组，以便提供监管、数据管理和 与14个临床研究团队(CRT)保持一致的协调人支持。CRT由临床医生和 来自多个学科的科学家和他们的临床研究人员，沿着与疾病相关的组织 主题。CRT讨论新的研究概念和试验；审查试验的团队兴趣、科学价值、重叠和 可行性；确定试验启动活动的优先顺序；审查试验时间表；以及审查当前试验的应计费用和参与者 安全。通过将支持与单个CRT相结合，O-CTSU可以将工作人员和其他资源与CRT联系起来 活动。 O-CTSU与Rogel共享资源和U-M单位互动，后者提供补充支持 为研究人员提供的服务，如癌症数据科学共享资源(CDS-SR)、罗杰尔肿瘤 反应评估核心(TRAC)，密歇根大学健康(密歇根大学健康)研究药房和 密歇根大学研究办公室的多个单位。毒品和犯罪问题办公室还支持罗杰尔有义务监测和确保 通过提供报告，在临床试验中代表整个生命周期的女性、少数民族和个人 仪表板和工具，以促进罗杰尔的全面计划，以解决这些问题。

PROJECT SUMMARY/ABSTRACT (CLINICAL PROTOCOL AND DATA MANAGEMENT) The Cancer Center Support Grant Clinical and Protocol Data Management (CPDM) requirements at the University of Michigan (U-M) Rogel Cancer Center are fulfilled through the Oncology Clinical Trials Support Unit (O-CTSU). The O-CTSU has evolved and strengthened its efforts during the project period with enhanced effectiveness, efficiency, and overall support for cancer clinical trials across U-M. The O-CTSU assists investigators in the creation, submission, review, activation, ct.gov registration, conduct, oversight, and closeout reporting of innovative cancer clinical trials in an efficient, regulatory compliant, and scientifically sound manner. By providing a comprehensive range of centralized services, including coordinator staff, standardized policies and procedures, training and education, informatics, and specimen processing, the O-CTSU helps ensure efficient and effective support for all cancer clinical trials. During the most recent period, O-CTSU support for clinical research was reorganized so that it provides regulatory, data management, and coordinator support in alignment with the 14 Clinical Research Teams (CRT). The CRTs consist of clinicians and scientists from multiple disciplines along with their clinical research staff, organized along disease-related themes. CRTs discuss new study concepts and trials; review trials for team interest, scientific merit, overlap and feasibility; prioritize trial startup activities; review trial timelines; and review current trial accrual and participant safety. By aligning support to the individual CRTs, the O-CTSU can link staffing and other resources to CRT activity. The O-CTSU interacts with Rogel Shared Resources and U-M units which provide complementary support services for investigators, such as the Cancer Data Science Shared Resource (CDS-SR), the Rogel Tumor Response Assessment Core (TRAC), University of Michigan Health (U-M Health) Research Pharmacy and multiple units of the U-M Office of Research. The O-CTSU also supports Rogel’s obligation to monitor and ensure representation of women, minorities, and individuals across the lifespan in clinical trials by providing reports, dashboards, and tools to facilitate Rogel’s comprehensive plans to address these matters.