Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs

描述(由申请人提供)：弗吉尼亚联邦大学(VCD)健康系统为神经紧急情况治疗试验(NETT)网络带来了非凡的专业知识和资源。通过其目前和过去对多中心试验的贡献，VCU Health System在开发和实施多站点方案以及参与NIH临床试验网络结构方面带来了经验。通过与VCU-Fairfax园区和Inova Health System的合作，VCU将支持NETT网络作为临床站点枢纽，拥有10家分支医院，服务于具有不同少数民族患者代表的城市、郊区和农村社区。VCU在临床试验管理和数据收集方面提供高素质、训练有素的人员，配备了一个经过验证的临床站点中心，能够在主要医疗中心和社区医院实施和监控方案。作为NETT网络的合作伙伴，VCU团队将与临床协调中心(CCC)、统计协调中心(SCC)和NINDS合作，为广泛的神经紧急情况实施创新的治疗方法。VCU中心将确保所有分支人员都得到了统一的培训和一致的支持，以维持质量控制并管理IRB审批、监管事务和合同执行。我们的临床站点中心将：1)维持一个急诊部门联盟，以进行NETT网络临床试验；2)培训分支站点的支持人员，了解临床研究方法、人类受试者保护、数据收集和数据输入；以及3)招募患者参加NETT网络临床试验，并在整个分支站点跟踪登记的患者。VCU临床中心网站将在现场和辐条急诊科指导NETT Network批准的协议，包括招募和监测研究参与者、相关数据收集以及与CCC合作的质量控制措施。我们将确认中心和分支站点严格遵守协议和标准操作程序，并将VCU财团收集的数据传输给CCC和SCC进行分析和解释。弗吉尼亚联邦大学卫生系统作为NETT网络临床站点中心的医生和科学家将在现场以及在形成我们中心周围辐条的每个主要医疗中心和社区医院实施针对一系列神经紧急情况的新疗法。

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.