Collaborative Pediatric Critical Care Research Network - Data Coordinating Center

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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.