Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 9758397
• 负责人: SCOTT Michael SCHUETZE
• 金额: $ 0.9万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9758397
• 关键词: Bioinformatics Shared Resource; Biometry; Cancer Center Support Grant; Catchment Area; Child; Clinic; Clinical; Clinical Cancer Center; Clinical Data; Clinical Oncology; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Support Unit; Contracts; Correlative Study; Data; Development; Diagnostic; Disease; Drops; Education; Enrollment; Ensure; Epidemiology; Female; Foundations; Funding; Goals; Grant; Informatics; Institution; Intervention; Intervention Trial; Life Cycle Stages; Michigan; Minority Enrollment; Mission; Monitor; Occupational activity of managing finances; Patient risk; Patients; Performance; Policies; Procedures; Protocols documentation; Reporting; Research Infrastructure; Research Personnel; Research Priority; Resources; Safety; Services; Specimen Handling; Standardization; System; Time; Training and Education; Translational Research; Translations; Universities; University of Michigan Comprehensive Cancer Center; Vision; authority; base; cancer clinical trial; cancer therapy; data management; demographics; improved; innovation; medical schools; multidisciplinary; patient oriented research; patient population; precision medicine; predictive marker; programs; quality assurance; response; sound; treatment trial; tumor

PROJECT SUMMARY/ABSTRACT (CLINICAL PROTOCOL AND DATA MANAGEMENT) The Cancer Center Support Grant (CCSG) Clinical and Protocol Data Management (CPDM) requirements at the University of Michigan Comprehensive Cancer Center (UMCCC) are fulfilled through the Oncology Clinical Trials Support Unit (O-CTSU). The O-CTSU, in partnership with the Children's CTSU, are the centralized offices that support the conduct of cancer clinical trials throughout the University of Michigan. The O-CTSU assists investigators in the creation, submission, review, activation, 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 standardized policies, procedures, training and education, informatics, and specimen processing, the O-CTSU helps ensure efficient and effective support for all cancer clinical trials. The primary unit responsible for executing the Data and Safety Monitoring Plan for investigator-initiated cancer clinical trials or studies supported on competitive grants is the Data and Safety Monitoring Committee, with the assistance of the Quality Assurance Review Core. The DSMC has the authority to take steps to minimize patient risk and maximize the safety of participating patients, suspend protocols based on data safety findings, and recommend closure to the PRC.

项目摘要/摘要（临床协议和数据管理） 癌症中心支持补助金（CCSG）临床和协议数据管理（CPDM）要求 密歇根大学综合癌症中心（UMCCC）通过肿瘤学临床试验实现 支持单元（O-CTSU）。 O-CTSU与儿童CTSU合作，是集中式办公室 支持密歇根大学的癌症临床试验的进行。 O-CTSU协助 创建，提交，审查，激活，行为，监督和关闭报告的调查人员 以高效，符合法规和科学的方式进行创新的癌症临床试验。通过提供 全面的集中服务，包括标准化政策，程序，培训和 教育，信息学和标本处理，O-CTSU有助于确保有效有效的支持 所有癌症临床试验。负责执行数据和安全监控计划的主要单位 研究者发起的癌症临床试验或支持竞争性补助的研究是数据和安全性 在质量保证审查核心的协助下，监测委员会。 DSMC拥有权威 要采取措施最大程度地降低患者风险并最大化参与患者的安全性，请暂停基于方案 关于数据安全发现，并建议关闭中国。