The specific objectives of the Clinical Research Support Office (CRSO) are to: ? provide streamlined protocol development, activation and implementation, and reduce the time to protocol activation ? increase the quality and quantity of investigator-initiated clinical trials and facilitate the translational research efforts of the Center by providing assistance in protocol development, implementation and data capture ? provide infrastructure for the conduct of early phase clinical trials ? provide a central core of personnel with expertise in all types of clinical trials management including protocol development and trial design, regulatory, compliance, and financial management ? provide central oversight of research personnel (clinical research coordinators and data managers), including initial and ongoing training, education, monitoring, and mentorship ? serve as the central office of record for all clinical trials conducted at the HDFCCC ? increase the participation of volunteer subjects in clinical trials with an emphasis on diversity ? seamlessly integrate informatics and biostatistical support provided by the Biostatistics and Translational Informatics Cores, including ensuring access to and training for a web-based protocol, data capture, and management system managed by the Translational Informatics Core The Clinical Research Support Office serves as the Office of Record and comprises several units, including the Early Phase Clinical Trials Unit, the Finance Unit, the Protocol Development and Regulatory Unit, and the Research Personnel Unit. These units work together to provide oversight, infrastructure support and quality control for the Center's entire clinical trials effort.
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