Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10627263
• 负责人: SCOTT Michael SCHUETZE
• 金额: $ 76.23万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10627263
• 关键词: Address; Calendar; Cancer Center; Cancer Center Support Grant; Cancer Control; Clinic; Clinical; Clinical Data; Clinical Protocols; Clinical Research; Clinical Trials; Clinical Trials Support Unit; Data; Data Science; Development; Developmental Therapeutics Program; Discipline; Disease; Effectiveness; Ensure; Glossary; Health; Hematopoiesis; Immunology; Individual; Informatics; Institutional Review Boards; Investigational Therapies; Leadership; Link; Longevity; Malignant Neoplasms; Medical; Medicine; Mentors; Michigan; Minority; Minority Groups; Monitor; Names; Participant; Pharmacy facility; Physician Executives; Policies; Population Sciences; Procedures; Protocols documentation; Reporting; Research; Research Personnel; Resource Sharing; Resources; Review Committee; Safety; Science; Scientist; Services; Signal Transduction; Specimen Handling; Standardization; System; Training and Education; Translational Research; Translations; Universities; Woman; cancer clinical trial; cancer genetics; dashboard; data integrity; data management; innovation; interest; medical schools; member; participant safety; programs; quality assurance; response; safety study; sound; timeline; tool; tumor; tumor microenvironment

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.

项目总结/摘要（临床方案和数据管理） 癌症中心支持补助金临床和方案数据管理（CPDM）要求 密歇根大学（U-M）Rogel癌症中心通过肿瘤学临床试验支持单位完成 （O-CTSU）。在项目期间，CTSU不断发展和加强其努力， 有效性，效率和整个U-M癌症临床试验的整体支持。 O-CTSU协助调查人员创建、提交、审查、激活、ct.gov注册、进行， 以高效、合规的方式监督和关闭创新癌症临床试验报告，以及 科学合理的方式。通过提供全面的集中式服务，包括协调员 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）保持一致的协调员支持。CRT由临床医生组成， 来自多个学科的科学家沿着他们的临床研究人员，组织沿着疾病相关的 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次序;审查试验时间表;审查当前试验累积和参与者 安全为代价的通过调整对各个中央应急小组的支助，中央应急小组办公室支助股可以将人员配置和其他资源与中央应急小组联系起来 活动 O-CTSU与Rogel共享资源和U-M单位互动，提供补充支持 为研究者提供的服务，如癌症数据科学共享资源（CDS-SR），Rogel肿瘤 反应评估核心（TRAC），密歇根大学健康（U-M健康）研究药房和 密歇根大学研究办公室的多个单位。O-CTSU还支持Rogel监督和确保 通过提供报告，在临床试验中代表妇女、少数民族和个人， 仪表板和工具，以促进罗格的全面计划，以解决这些问题。