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: 10170452
• 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 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10170452
• 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; 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.

紧急护理通常会决定患者的结果，因为准确及时至关重要 受伤或疾病早期阶段的诊断和干预措施。创新的策略 NIH创建了紧急护理临床试验网络（Siren），以进行调查 跨器官系统和疾病的不同急诊治疗，而无需重复努力， 从而最大程度地减少启动成本并促进规模经济。数据协调的目的 警笛的中心（DCC）是为了提供全面的数据管理和统计基础架构 支持该网络进行高质量临床试验的目标，该试验将改善 神经系统（不包括中风），心脏，呼吸道，血液学和创伤紧急事件。 DCC的角色是与网络中涉及的各方建立协作关系， 提供有效的标准化中央数据管理，可产生高质量数据，提供统计 支持临床试验的计划和执行，为各种 利益相关者并通过参与手稿和演示准备以及促进数据共享 及时提交公共使用数据集。为此，医疗的数据协调单元（DCU） 南卡罗来纳大学已经开发了一个基于网络的综合综合数据和项目 管理系统，WebDCU™，可以通过参与临床站点的分布数据输入 广泛的数据质量控制。它还提供了有效管理运营活动的必要工具 在多个试验中，同时确保遵守FDA法规和准则。使用WebDcu 系统，我们将开发，实施和维护一个中央数据库，该数据库简化并最大化效率 在数据收集，处理和监测临床数据的管理中。此外，WebDCU™ 将纳入试验管理信息，这些信息将为所有学习操作活动提供全力支持 警笛。与个人研究的首席研究员和我们的警笛合作伙伴合作（CCC，Hubs， 治理委员会），DCU将：为创新和有效的协议开发做出贡献 （包括研究设计和案例报告表格开发）；监督数据质量；生成报告 DSMB，监管方和研究团队；进行临时和最终分析和研究 通过演示和出版物的结果；并创建用于数据共享的公共使用数据集。