Clinical Protocol and Data Management

临床方案和数据管理

• 批准号: 10438639
• 负责人: SCOTT Michael SCHUETZE
• 金额: $ 55.59万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10438639
• 关键词: Bioinformatics Shared Resource; Biometry; Cancer Center Support Grant; Catchment Area; Child; Clinic; Clinical; Clinical Cancer Center; Clinical Data; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Clinical Trials Support Unit; Contracts; Correlative Study; Data; Data Management Resources; Development; Diagnostic; Disease; Drops; Education; Enrollment; Ensure; Epidemiology; Female; Foundations; Funding; Goals; Grant; Informatics; Infrastructure; 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 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; multi-site trial; 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(临床方案和数据管理) 癌症中心支持拨款(CCSG)临床和方案数据管理(CPDM)要求位于 密歇根大学综合癌症中心(UMCCC)通过肿瘤学临床试验完成 支持股(O-CTSU)。儿童问题特别工作组与儿童问题特别工作组合作，是中央办公室， 支持在密歇根大学开展癌症临床试验。O-CTSU助攻 调查人员创建、提交、审查、激活、进行、监督和结案报告 以高效、合规和科学合理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，包括标准化的政策、程序、培训和 在教育、信息学和标本处理方面，O-CTSU帮助确保高效和有效地支持 所有癌症临床试验。负责执行《数据和安全监测计划》的主要单位 研究人员发起的癌症临床试验或研究由竞争性赠款支持是数据和安全性 监督委员会，在质量保证审查核心的协助下。Dsmc有权 采取措施最大限度地减少患者风险，最大限度地提高参与患者的安全性，暂停基于以下原则的方案 关于数据安全调查结果，并向中华人民共和国建议关闭。