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.

急诊护理通常决定患者的结局，因为准确和及时地做出 在受伤或疾病的早期阶段进行诊断和干预。创新的战略 紧急护理临床试验网络(SIREN)是由美国国立卫生研究院创建的，以使调查 跨器官系统和疾病的不同紧急护理治疗，没有重复的努力， 从而将启动成本降至最低，并促进规模经济。数据协调的目的 中心(DCC)为警报器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，以改善患者的预后 神经系统(不包括中风)、心脏、呼吸、血液和创伤急救事件。 DCC的作用是与网络中涉及的各方建立合作关系，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，提供统计 支持临床试验的计划和执行，准备和传播各种临床试验的试验报告 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，医疗中心的数据协调股(DCU) 南卡罗来纳大学开发了一个基于网络的综合数据和项目 管理系统WebDCU™，支持从参与的临床站点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运营活动所需的工具 跨多个试验，同时确保遵守FDA的法规和指南。使用WebDCU 作为一个系统，我们将开发、实施和维护一个中央数据库，以精简和最大限度地提高效率 在临床数据的收集、处理和监测方面的管理。此外，WebDCU™ 将纳入试验管理信息，为#年的所有研究业务活动提供全面支持 警报器。与个人研究首席调查员和SIREN(CCC，HUBS， 治理委员会)，DCU将：为创新和高效的议定书制定作出贡献 (包括研究设计和病例报告表开发)；监督数据质量；为 Dsmb、监管各方和研究团队；对研究进行临时和最终分析和传播 通过演示文稿和出版物取得成果；并创建公共使用数据集，用于数据共享。