Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center

急诊护理通常决定了患者的预后，因为在损伤或疾病的早期阶段进行准确，及时的诊断和干预至关重要。创新紧急护理临床试验网络战略（SIREN）由NIH创建，旨在研究跨越器官系统和疾病的不同紧急护理治疗方法，而无需重复努力，从而最大限度地降低启动成本并促进规模经济。SIREN数据协调中心（DCC）的目的是提供全面的数据管理和统计基础设施，以支持该网络进行高质量临床试验的目标，这些临床试验将改善神经系统、心脏、呼吸系统、血液系统和创伤紧急事件患者的结局。本更新申请是对RFA-NS-22-013的回应，描述了我们将继续作为SIREN网络的DCC提供的特性、功能和协调。 DCC的作用是与网络中的所有参与方建立合作关系，并提供高效和标准化的中央数据管理，以产生高质量的数据，为临床试验的规划和执行提供统计支持，为各利益相关方编写和分发试验报告，并促进数据共享。为此，南卡罗来纳州医科大学的数据协调单位（DCU）开发了一个基于网络的综合集成数据和项目管理系统WebDCU™，该系统可通过广泛的数据质量控制从参与的临床研究中心进行分布式数据输入。DCU还提供必要的工具，以有效管理多项试验的运营活动，同时确保符合FDA法规和指南。使用WebDCU数据库系统，我们开发、实施和维护了一个中央数据库，该数据库简化了数据收集、处理和临床数据监测的管理并最大限度地提高了效率。此外，WebDCU™还整合了试验管理信息，为SIREN的所有研究操作活动提供全面支持。与个体研究主要研究者和SIREN的合作伙伴合作（CCC、中心、治理委员会），DCU将继续：（包括研究设计和病例报告表开发）;监督数据质量;为DSMB、监管方和研究团队生成报告;进行中期和最终分析，并通过介绍和出版物传播研究结果;创建供公众使用的数据集，以供数据共享。SIREN在过去5年的资助期内启动了5项大型、简单的多中心试验，并将在下一个资助期内启动至少4项。该网络旨在通过探索临床试验设计的创新，通过患者利益相关者更好和更早地参与试验计划，以及通过实施和执行试验的创造性改进，来改变紧急研究企业。

Emergency care often determines the patient outcome as it is critical to make accurate, timely diagnoses and interventions during the early stages of the injury or disease. The Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) was created by the NIH to enable the investigation of different emergency care treatments spanning across organ systems and diseases without duplication of effort, thereby minimizing start- up costs and promoting economies of scale. The purpose of the Data Coordinating Center (DCC) for SIREN is to provide a comprehensive data management and statistical infrastructure to support the network’s goal of conducting high quality clinical trials that will improve outcomes for patients with neurologic, cardiac, respiratory, hematologic and trauma emergency events. This renewal application, in response to RFA-NS-22-013, describes the features, functions and coordination we will continue to provide as the DCC for the SIREN Network. The DCC’s role is to establish a collaborative relationship with all parties involved in the Network and provide efficient and standardized central data management that yields high quality data, provide statistical support in the planning and execution of the clinical trials, prepare and disseminate trial reports for the various stakeholders and facilitate data sharing. To this end, the Data Coordination Unit (DCU) at the Medical University of South Carolina has developed a web-based comprehensive integrated data and project management system, WebDCU™, that enables distributed data entry from the participating clinical sites with extensive data quality control. The DCU also provides the necessary tools to efficiently manage operational activities across multiple trials, while ensuring compliance with FDA regulations and guidelines. Using the WebDCU system, we have developed, implemented and maintained a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical data. In addition, the WebDCU™ incorporates trial management information that provides full support for all study operational activities in SIREN. In collaboration with the individual study Principal Investigator and our partners of SIREN (CCC, Hubs, Governance Committees), the DCU will continue to: contribute to the innovative and efficient protocol development (including study design and case report form development); oversee data quality; generate reports for the DSMB, regulatory parties and the study teams; conduct interim and final analysis and dissemination of study results via presentations and publications; and create public use datasets for data sharing. SIREN initiated 5 large, simple multicenter trials over the previous 5 year grant period and will initiate at least 4 more in the next grant period. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs, by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.