Collaborative Pediatric Critical Care Research Network - Data Coordinating Center

项目摘要 2005年，尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD) 建立了儿科重症监护协作研究网络(CPCCRN)，以支持多机构 危重儿童随机对照试验和观察性研究。犹他大学是 准备支持CPCCRN从7个临床站点扩展到24个站点的建议，这将加强- CPCCRN在脓毒症所致多器官功能障碍中的个性化免疫调节作用 综合征(MODS)研究。DCC将在确保监管合规方面发挥重要的独立作用， 保护人体受试者，保证试验结果的完整性。 疾病预防控制中心有两个特殊的fic目标：(1)提供独立的临床和生物统计学领导和专业知识， 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fiNAL研究分析、研究结果的发布以及公共用途研究的生产 数据集。(2)为CPCCRN提供后勤支持(包括礼宾资金的fi财务管理)，我们- ING开发和跟踪关键文件的先进通信和信息学工具，包括 学习方案、常见问题解答文件、操作手册、培训材料、IRB和其他规范性文件； 研究出版物、DSMB报告，并向NICHD提供会计信息。 在CPCCRN第一个15年的fi期间，DCC发挥了关键的领导作用。临床专业知识有 实现了有效的fi设计和CPCCRN研究的优先顺序，以最大限度地提高生产率；生物统计学专业知识 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- 自该中心成立以来，Nology使其能够在fi内部进行有效的沟通。我们认为，初选 评判DCC的标准是由 DCC。调查人员已成功角逐9个R01奖项，以提高CPCCRN的生产率， 开展了36项研究，出版了119份同行评议的出版物。CPCCRN将继续其突出的 由犹他大学DCC贡献的独特优势的表现。

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.