Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center (DCC)

紧急护理临床试验网络：紧急护理临床试验网络 (SIREN) 的创新策略 - 数据协调中心 (DCC)

• 批准号: 9976602
• 负责人: VALERIE L DURKALSKI
• 金额: $ 34.35万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9976602
• 关键词: Accident and Emergency department; Address; Cardiac; Cardiovascular system; Case Report Form; Clinical; Clinical Data; Clinical Trials; Clinical Trials Network; Collaborations; Communication; Conduct Clinical Trials; Data; Data Collection; Data Coordinating Center; Data Reporting; Data Set; Development; Diagnosis; Disease; Emergency Care; Emergency Situation; Emergency research; Ensure; Environment; Event; Goals; Guidelines; Health Sciences; Hematology; Individual; Information Management; Information Systems; Infrastructure; Injury; Intervention; Investigation; Leadership; Manuscripts; Medical; Monitor; Network Infrastructure; Neurologic; Neurology; Online Systems; Patient-Focused Outcomes; Patients; Phase; Positioning Attribute; Preparation; Principal Investigator; Procedures; Public Health; Publications; Quality Control; Regulation; Reporting; Research; Research Design; Resources; Role; Scientist; South Carolina; Specific qualifier value; Spinal cord injury; Standardization; Status Epilepticus; Stroke; Study Subject; System; Therapy Clinical Trials; Time; Trauma; Traumatic Brain Injury; United States National Institutes of Health; Universities; Work; acute care; base; body system; central database; clinical center; clinical research site; clinical trial analysis; cost; data management; data quality; data sharing; data standards; design; distributed data; electronic data; emergency settings; experience; implementation trial; improved; improved outcome; innovation; multidisciplinary; operation; pragmatic trial; protocol development; quality assurance; recruit; respiratory; scientific organization; support network; tool; trial design

Emergency care often determines the patient outcome as it is critical to make accurate and 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 (not including stroke), cardiac, respiratory, hematologic and trauma emergency events. 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 by participating in manuscript and presentation preparation as well as the timely submission of public use datasets. 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. It 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 will develop, implement and maintain a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical data. In addition, the WebDCU™ will incorporate trial management information that will provide 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: 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.

紧急护理通常决定患者的结果，因为准确和及时地进行 在损伤或疾病的早期阶段进行诊断和干预。创新战略 EmeRgENcy Care临床试验网络（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，而无需重复工作， 从而最小化启动成本并促进规模经济。数据协调的目的 SIREN数据中心（DCC）将提供全面的数据管理和统计基础设施， 支持该网络的目标，即进行高质量的临床试验，以改善患者的结局， 神经系统（不包括中风）、心脏、呼吸、血液和创伤紧急事件。 发展协调委员会的作用是与参与网络的所有各方建立合作关系， 提供高效和标准化的中央数据管理，以产生高质量的数据， 支持临床试验的计划和执行，为各种临床试验准备和分发试验报告。 通过参与手稿和演示文稿的准备以及 及时提交公共使用数据集。为此，医疗保健中心的数据协调股（DCU） 南卡罗来纳州大学开发了一个基于Web的综合集成数据和项目 管理系统WebDCU™，可从参与的临床研究中心进行分布式数据输入， 广泛的数据质量控制。它还提供了有效管理业务活动的必要工具 同时确保符合FDA法规和指南。使用WebDCU 系统，我们将开发，实施和维护一个中央数据库，以简化和最大限度地提高效率 数据收集、处理和临床数据监测的管理。此外，WebDCU™ 将纳入试验管理信息，为所有研究操作活动提供全面支持， 警报。与个体研究主要研究者和我们的SIREN合作伙伴（CCC，Hubs， 管理委员会），DCU将： （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;进行中期和最终分析并传播研究 通过介绍和出版物取得成果;并创建供公众分享数据的数据集。