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

急诊护理往往决定患者的预后，因为在损伤或疾病的早期阶段做出准确、及时的诊断和干预是至关重要的。紧急护理临床试验网络创新战略（SIREN）是由美国国立卫生研究院创建的，旨在使不同的紧急护理治疗跨越器官系统和疾病的调查没有重复的努力，从而最大限度地降低启动成本和促进规模经济。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，以支持网络开展高质量临床试验的目标，从而改善神经、心脏、呼吸、血液学和创伤紧急事件患者的结果。这份更新申请是对RFA-NS-22-013的回应，描述了我们将继续作为DCC为SIREN网络提供的特性、功能和协调。DCC的作用是与参与网络的所有各方建立合作关系，并提供有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，为各利益攸关方准备和分发试验报告，并促进数据共享。为此，南卡罗来纳医科大学的数据协调单位（Data Coordination Unit， DCU）开发了一个基于网络的综合数据和项目管理系统WebDCU™，该系统能够从参与的临床站点进行分布式数据输入，并具有广泛的数据质量控制。DCU还提供必要的工具，以有效地管理跨多个试验的操作活动，同时确保符合FDA法规和指导方针。使用WebDCU系统，我们开发、实施和维护了一个中央数据库，该数据库简化并最大限度地提高了数据收集、处理和临床数据监测管理的效率。此外，WebDCU™集成了试验管理信息，为SIREN中的所有研究操作活动提供全面支持。在与个体研究首席研究员和我们的合作伙伴SIREN （CCC, Hubs，治理委员会）的合作下，DCU将继续：促进创新和高效的方案开发（包括研究设计和病例报告表开发）；监督数据质量；为资讯科技发展局、规管团体及研究小组撰写报告；进行中期和最终分析，并通过演讲和出版物传播研究结果；并为数据共享创建公共使用数据集。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至少启动4项试验。该网络旨在通过探索临床试验设计方面的创新，通过更好和更早地让患者利益攸关方参与试验规划，以及通过创造性地改进试验的实施和执行，改变应急研究事业。

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.