Clinical Trial Operations Core

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ABSTRACT – Clinical Trial Operations Core (Core 2) The Clinical Trial Operations Core provides critical research support to promote seamless and efficient development, recruitment and conduct of the clinical trials in the Duke Brain SPORE's three projects and clinical studies proposed by Developmental and Career Enhancement awardees. Bringing strong expertise in neuro-oncology and clinical trial operations to the SPORE, the Core ensures the safe and efficient conduct of clinical studies (Aim 1) and recruitment, consent and enrollment of a diverse group of subjects for biospecimen collection and clinical studies (Aim 2). Through these Aims, the Core provides critical oversight of the full range of clinical trial activities, including study design, protocol preparation, research staff training, patient recruitment, patient evaluation during treatment and follow-up, assessment and treatment of complications, and evaluation of patient outcomes. To ensure rigorus trial conduct, the Core mainatins a full portfolio of standard operating procedures (SOPs). In addition, the Core is fully integrated with other Duke Brain SPORE components to ensure seamless research coordination. For example, in partnership with the Administrative Core, this Clinical Trial Operations Core provides regulatory specialists to meet the requirements of the federal government, Duke University Health System (DUHS), and Duke Cancer Institute (DCI) and avoid conflict of interest (COI). This Core also collaborates with the Biostatistics and Bioinformatics Core (Core 1) in the development of the protocol electronic case report forms (eCRFs), study database, data management, quality assurance, and summarization of clinical data for presentation at international meetings and manuscript publications. Finally, the Clinial Trial Operations Core supplies electronic data acquisition and documentation services for the Biostatistics and Bioinformatics Core (Core 1) and facilitates tissue biobanking with the Biospecimen and Immune Monitoring Core (Core 3). By enchancing interdisciplinary communictation and collaboration in this way, the Core supports the the SPORE's commitment to both translate laboratory findings to the clinic and collect clinical material to be studied in the laboratory.