The Clinical Research Office (CRO) coordinates the activities and provides oversight for clinical research studies conducted by Cancer Center Members. Specifically, the objectives of the Shared Resource are to: Coordinate the clinical research studies initiated by Cancer Center Members through assurance of effective data management, pharmacy support, nursing management, IRB approval, record keeping, implementation, and close-out. Gather and provide information on protocol availability, eligibility, and accrual. Prioritize and coordinate, with the appropriate Cancer Center Program Leaders institutional clinical studies of Cancer Center Members, those of cooperative groups (e.g., GOG, SWOG, NSABP) and other studies (e.g., pharmaceutical). Perform quality control and internal auditing for Cancer Center clinical trials. Internal audits include monitoring 1) compliance with the informed consent process and stated eligibility criteria, 2) appropriate delivery of treatment and implementation of treatment modifications, 3) reporting of clinical outcome and toxicity, and 4) accurate recording of data and 5) maintenance of research subject confidentiality. Provide assistance to Principal Investigators with clinical research informatics needs for their individual protocols. Services include: Identification of the necessary datasets;development of study-specific case report forms;monitoring of quality of data;and serving a liaison function with the Biostatistics Shared Resource for the purpose of providing data for statistical analysis.
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