Clinical Protocol and Data Management

点击翻译按钮获取中文摘要

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.