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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要 2005 年，尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 建立儿科重症监护协作研究网络 (CPCCRN) 以支持多机构犹他大学对危重儿童进行随机对照试验 (RCT) 和观察性研究。准备支持 CPCCRN 从 7 个临床中心扩大到 24 个中心的提议，这将 CPCCRN 能够对脓毒症引起的多器官功能障碍进行个性化免疫调节 DCC 将在确保监管合规性方面发挥重要的独立作用，人类受试者的保护和试验结果的完整性。 DCC 有两个具体目标：(1) 提供独立的临床和生物统计领导力和专业知识，协助研究和方案设计、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、现场监测、研究报告、中期和最终研究分析、研究结果的发布以及公共使用研究的制作 (2) 为 CPCCRN 提供后勤支持（包括协议资金的财务管理），us- 使用先进的通信和信息学工具来开发和跟踪关键文档，包括研究方案、常见问题解答文件、操作手册、培训材料、IRB 和其他监管文件，研究出版物、DSMB 报告以及向 NICHD 提供会计信息。 DCC 在 CPCCRN 的前 15 年中发挥了至关重要的领导作用。实现 CPCCRN 研究的高效设计和优先排序，以最大限度地提高生物统计专业知识；在研究开发和实施的每个阶段都提供了最先进的信息学技术；自成立以来，nology 就实现了 CPCCRN 内部的高效沟通。我们相信这是首要的。判断 DCC 的标准是由研究中心支持的研究中心和研究人员的生产力 DCC 的研究人员已成功角逐九项 R01 奖项，以提高 CPCCRN 的生产力，实施 36 项研究，产生 119 份同行评审出版物。 CPCCRN 将继续其杰出表现。犹他大学 DCC 所贡献的独特优势。