Clinical Protocol and Data Management

项目总结/摘要（临床方案和数据管理） 癌症中心支持补助金（CCSG）临床和方案数据管理（CPDM）要求 密歇根大学综合癌症中心（UMCCC）通过肿瘤临床试验完成 支助股（O-CTSU）。儿童和青少年支助股与儿童问题支助股合作，是集中办公室， 支持在密歇根大学进行癌症临床试验。O-CTSU协助 研究者在创建、提交、审查、激活、执行、监督和关闭报告中 创新的癌症临床试验，以高效、符合法规和科学合理的方式进行。通过提供 一系列全面的集中服务，包括标准化的政策、程序、培训和 教育，信息学和标本处理，O-CTSU有助于确保高效和有效的支持， 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 由制药商发起的癌症临床试验或由竞争性赠款支持的研究是数据和安全 监测委员会，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降低患者风险并最大限度地提高参与患者的安全性， 并建议PRC关闭。

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.