Collaborative Pediatric Critical Care Research Network - Data Coordinating Center

儿科重症监护协作研究网络 - 数据协调中心

• 批准号: 10248813
• 负责人: Jonathan Michael Dean
• 金额: $ 139.29万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-13 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10248813
• 关键词: Accounting; Applied Research; Award; Biological; Biometry; Child; Childhood; Clinical; Clinical Investigator; Clinical Trials Data Monitoring Committees; Collaborations; Communication; Communication Tools; Critical Care; Critically ill children; Data Collection; Data Coordinating Center; Data Set; Development; Emergency Care; Enrollment; Funding; Heart Arrest; Infant; Informatics; Institution; Institutional Review Boards; International; Leadership; Logistics; Manuals; Medical; Medical Informatics; Methods; Monitor; Morbidity - disease rate; Multiple Organ Failure; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Observational Study; Occupational activity of managing finances; Pediatric Intensive Care Units; Peer Review; Performance; Pharmaceutical Preparations; Pharmacology; Play; Principal Investigator; Production; Productivity; Protocols documentation; Publications; Randomized Controlled Trials; Reporting; Research; Research Personnel; Role; Sepsis; Site; Specimen; Technology; Testing; Therapeutic; Training; Universities; Utah; clinical research site; data management; design; expectation; experience; human subject protection; immune function; immunoregulation; informatics tool; innovation; medical schools; mortality; natural hypothermia; operation; pediatric emergency; pediatric pharmacology; tool development; trial design

Project Summary In 2005, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Collaborative Pediatric Critical Care Research Network (CPCCRN) to support multi-institutional randomized controlled trials (RCTs) and observational studies in critically ill children. The University of Utah is prepared to support the proposed expansion of CPCCRN from seven clinical sites to 24 sites, which will en- able CPCCRN to carry out the Personalized Immunomodulation in Sepsis-induced Multiple Organ Dysfunction Syndrome (MODS) study. The DCC will play an important independent role in assuring regulatory compliance, human subjects protection, and integrity of the trial results. The DCC has two Specific Aims: (1) Provide independent clinical and biostatistical leadership and expertise, assistance in study and protocol design, study implementation and management, tracking and delivery methods for study drugs and biological specimens, study training, data collection and management, site monitoring, study reporting, interim and final study analyses, publication of study results, and production of public use research datasets. (2) Provide logistical support for CPCCRN (including financial management of protocol funds), us- ing advanced communication and informatics tools for development and tracking of critical documents, including study protocols, FAQ documents, Manuals of Operation, training materials, IRB and other regulatory documents, study publications, DSMB reports, and provision of accounting information to NICHD. The DCC has played a crucial leadership role during the first 15 years of the CPCCRN. Clinical expertise has enabled efficient design and prioritization of CPCCRN studies to maximize productivity; biostatistical expertise has been provided at every stage of study development and implementation; state of the art informatics tech- nology has enabled efficient communication within CPCCRN since its inception. We believe that the primary criterion by which a DCC should be judged is the productivity of the sites and investigators supported by the DCC. Investigators have successfully competed for nine R01 awards to increase the productivity of CPCCRN, implementing 36 studies resulting in 119 peer reviewed publications. The CPCCRN will continue its outstanding performance with the unique strengths that are contributed from the University of Utah DCC.

项目摘要 2005年，Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD） 建立了协作小儿重症监护研究网络（CPCCRN）以支持多机构 重症儿童的随机对照试验（RCT）和观察性研究。犹他大学是 准备支持提议将CPCCRN从七个临床部位扩展到24个地点的拟议扩展 能够在败血症引起的多器官功能障碍中执行个性化免疫调节 综合征（mod）研究。 DCC将在确保法规合规性中发挥重要独立作用， 人类受试者的保护和试验结果的完整性。 DCC具有两个特定的目的：（1）提供独立的临床和生物统计领导和专业知识， 协助研究和协议设计，研究实施和管理，跟踪和交付方法 用于研究药物和生物标本，研究培训，数据收集和管理，现场监控，研究 报告，临时和最终研究分析，研究结果的发布以及公共使用研究的生产 数据集。 （2）为CPCCRN（包括协议基金的财务管理）提供后勤支持，美国 为开发和跟踪关键文档的开发和跟踪工具，包括 研究方案，常见问题文件，操作手册，培训材料，IRB和其他监管文件， 研究出版物，DSMB报告并向NICHD提供会计信息。 DCC在CPCCRN的第15年中扮演了至关重要的领导角色。临床专业知识具有 启用了CPCCRN研究的有效设计和优先级，以最大程度地提高生产率；生物统计专业知识 在研究开发和实施的每个阶段都提供了；最新信息信息技术 - 自从其成立以来，NOLOGY已在CPCCRN内实现了有效的通信。我们相信主要 应判断DCC的标准是站点和调查人员支持的生产力 DCC。研究人员已成功竞争了9个R01奖项，以提高CPCCRN的生产率， 实施36项研究，导致119个同行审查的出版物。 CPCCRN将继续其出色 犹他大学DCC贡献的独特优势的表现。