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; 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.

项目摘要/摘要（临床协议和数据管理） 癌症中心支持授予临床和协议数据管理（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部门实现 （O-CTSU）。 O-CTSU在项目期间进化并加强了其努力，并增强了 跨U-M的癌症临床试验的有效性，效率和总体支持。 O-CTSU协助研究人员创建，提交，审查，激活，CT.GOV注册，行为， 在高效，符合法规的情况下对创新癌症临床试验的监督和关闭报告 科学的态度。通过提供全面的集中服务，包括协调员 员工，标准化政策和程序，培训和教育，信息信息和标本处理， O-CTSU有助于确保对所有癌症临床试验的有效支持。在最近时期， O-CTSU对临床研究的支持得到了重组，因此它提供了监管，数据管理和 与14个临床研究团队（CRT）保持一致的协调支持。 CRT由临床医生和 来自多个学科的科学家以及其临床研究人员，沿着疾病有关 主题。 CRT讨论新的研究概念和试验；审查团队兴趣，科学功绩，重叠和重叠的审查试验 可行性;优先考虑试用启动活动；审查审判时间表；并审查当前的试验准确性并参与 安全。通过对单个CRT的支持，O-CTSU可以将人员配备和其他资源链接到CRT 活动。 O-CTSU与Rogel共享资源和U-M单位相互作用，这些资源提供了完整的支持 研究人员的服务，例如癌症数据科学共享资源（CDS-SR），Rogel肿瘤 密歇根大学健康（U-M Health）研究药房的反应评估核心（TRAC）和 U-M研究办公室的多个单位。 O-CTSU还支持Rogel监视和确保 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，以促进罗杰尔（Rogel）的全面计划解决这些问题。