Neurological Emergencies Treatment Trials (NETT) Network Clinical Site Hubs

神经急症治疗试验 (NETT) 网络临床站点中心

• 批准号: 7924230
• 负责人: Joseph P ORNATO
• 金额: $ 19.41万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7924230
• 关键词: Accident and Emergency department; Acute; American; American College of Surgeons; Asians; Award; Back; Brain; Caring; Catchment Area; Censuses; Cities; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Collaborations; Commit; Communities; Community Hospitals; Contracts; County; Credentialing; Data; Data Collection; Discipline of Nursing; District of Columbia; Doctor of Philosophy; Dose; Drug Kinetics; Emergency Medicine; Emergency treatment; Enrollment; Ensure; Goals; Health; Health system; Healthcare; Hispanics; Hospitals; Human Resources; International; Measures; Medical; Medical center; Minority; Monitor; Multicenter Trials; National Institute of Neurological Disorders and Stroke; Nervous System Trauma; Neurological emergencies; Neurologist; Neurosurgeon; Nurses; Nursing Research; Participant; Patient Recruitments; Patients; Physicians; Pilot Projects; Population; Principal Investigator; Procedures; Protocols documentation; Qualifying; Quality Control; Recording of previous events; Recruitment Activity; Regulatory Affairs; Rehabilitation therapy; Research; Research Ethics Committees; Research Methodology; Resources; Rural Community; Scientist; Site; Spinal cord injury; Structure; Training; Training Support; United States National Institutes of Health; Universities; Virginia; Visit; Work; base; clinical research site; evidence base; experience; human subject protection; innovation; neurochemistry; programs; statistical center; suburb; trauma centers; treatment trial

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.

描述（由申请人提供）：弗吉尼亚联邦大学（VCD）卫生系统为神经系统紧急情况治疗试验（NETT）网络带来了卓越的专业知识和资源。通过其当前和过去对多中心试验的贡献，VCU卫生系统带来了开发和实施多中心方案以及参与NIH临床试验网络结构的经验。VCU将与VCU-Fairfax校区和Inova Health System合作，支持NETT网络作为临床站点中心，拥有10家辐条医院，为城市、郊区和农村社区提供服务，其中包括不同的少数族裔患者代表。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中心中心，能够在主要医疗中心和社区医院实施和监测方案。作为NETT网络的合作伙伴，并与临床协调中心（CCC），统计协调中心（SCC）和NINDS合作，VCU团队将致力于为广泛的神经系统紧急情况实施创新治疗。VCU中心将确保所有分支人员都接受了统一的培训并得到一致的支持，以保持质量控制并管理IRB批准、法规事务和合同执行。我们的临床研究中心将：1）维持一个急诊科联盟来进行NETT网络临床试验; 2）在临床研究方法、人类受试者保护、数据收集和数据输入方面培训分支站点的支持人员; 3）招募患者参加NETT网络临床试验，并在整个分支站点跟踪招募的患者。VCU临床中心将指导NETT网络批准的现场和辐条急诊室方案，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。我们将确认在中心和辐射站点严格遵守协议和标准操作程序，并将VCU联盟收集的数据传输给CCC和SCC进行分析和解释。弗吉尼亚联邦大学卫生系统的医生和科学家作为NETT网络临床站点中心，将在现场和每个主要医疗中心和社区医院实施一系列神经系统紧急情况的新疗法，这些医院形成了我们中心周围的辐条。