Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs

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DESCRIPTION (provided by applicant): The Virginia Commonwealth University (VCD) Health System brings exceptional expertise and resources to the Neurological Emergencies Treatment Trials (NETT) Network. Through its current and past contributions to multicenter trials, the VCU Health System brings experience in developing and implementing multisite protocols and participating in the NIH clinical trial network structure. In partnership with the VCU-Fairfax campus and Inova Health System, VCU will support the NETT Network as a Clinical Site Hub with 10 spoke hospitals serving a mix of urban, suburban, and rural communities with diverse minority patient representation. VCU offers highly qualified, trained personnel in clinical trial management and data collection, staffing a proven Clinical Site Hub capable of implementing and monitoring protocols across major medical centers and community hospitals. As a partner in the NETT Network and in conjunction with the Clinical Coordinating Center (CCC), Statistical Coordinating Center (SCC) and the NINDS, the VCU team will work toward implementing innovative treatments for a broad spectrum of neurological emergencies. The VCU Hub will ensure all spoke personnel have been uniformly trained and consistently supported to maintain quality control and to manage IRB approvals, regulatory affairs, and contract execution. Our Clinical Site Hub will: 1) maintain a consortium of emergency departments to conduct NETT Network clinical trials; 2) train support personnel at spoke sites in clinical research methods, human subjects' protection, data collection, and data entry; and 3) recruit patients into NETT Network clinical trials and follow enrolled patients throughout the spoke sites. The VCU Clinical Hub Site will direct NETT Network-approved protocols on site and at spokes emergency departments, including the recruitment and monitoring of study participants, associated data collection, and quality control measures in collaboration with the CCC. We will confirm that protocols and standard operating procedures are strictly followed at the Hub and spoke sites and transmit data collected by the VCU consortium to the CCC and SCC for analysis and interpretation. Physicians and scientists of the Virginia Commonwealth University Health System as a NETT Network Clinical Site Hub will implement new therapies for a spectrum of neurological emergencies both on site and in each of the major medical centers and community hospitals that form the spokes around our Hub.