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.

急诊护理往往决定病人的预后，因为它是至关重要的，使准确和及时