The primary goal of the M. D. Anderson Cancer Center Lymphoma SPORE Clinical Research Core is to bridge the translational research with clinical research by 1) coordinating the development of clinical trials, 2) assisting in patient accrual, 3) reporting adverse events to appropriate agencies, and 4) providing quality control on clinical trial data. The Clinical Research Core provides a critical link between clinical research and the specific projects and cores. The Clinical Research Core is co-directed by Anas Younes, MD, and Peter McLaughlin, MD. Other key members of the Clinical Research Core are the Research Nurse Manager, Coordinator of Regulatory Compliance, Data Analyst/Auditor, and Advanced Nurse Practitioner/Research Nurse. The Research Nurse Manager will be responsible for supervising all research nurses in the core and ensuring their proper training. The Coordinator of Regulatory Compliance will be responsible for all regulatory aspects of protocol submission, approval, amendments, and communication with the Institutional Review Board (IRB) and the sponsor. The data analyst/auditor will perform periodic audits on protocols, and the Advanced Practice Nurse will be responsible for continuing education for the research staff. The Clinical Research Core will provide support to all projects and investigators involved in Projects. The Clinical Research Core will interact with the Biostatistics Core for the statistical design of clinical trials and will provide clinically-based patient data to the Biostatistics Core. It will also interact with the Biospecimens Core by procuring and transporting human specimens and by providing clinical data related to the specimens. The Core will also interact with the Administrative core to coordinate studies and communication with the NCI and other lymphoma SPORE programs.
The Clinical Research Core will coordinate all aspects of clinical research proposed in this SPORE application, including clinical trials conducted at MDACC and the UNMC. This application has 4 IRB- approved studies enrolling patients in the first year of this proposal.
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