Clinical Protocol and Data Management

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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.