The Collaborative Pediatric Critical Care Research Network (CPCCRN) is being established to conduct randomized controlled trials and observational studies to improve the outcome of children requiring critical care. This proposal by the University of Utah to be the data coordinating center for the CPCCRN has two specific aims: (1) establish and maintain the infrastructure for the CPCCRN; and (2) provide credible, collaborative leadership for the CPCCRN. The applicant is the data coordinating center for a recently established 25 hospital pediatric emergency care research network, providing it with leadership experience in the coordination and support of a new pediatric network. The applicant will use an electronic virtual office to support network communications, and will provide logistical support including meeting arrangements, tracking critical document and publications, circulating reports and newsletters, and preparation of meeting materials including meeting minutes. We propose, within the first six months, to create a registry database of critically ill children seen in the network, to facilitate feasibility analyses and accrual projections for potential trials. We will formalize our relationship with the NIH/NHLBI funded Adult Respiratory Distress Syndrome Network (ARDS Network) data coordinating center, enabling unique sharing of protocols and electronic tools between the new pediatric network and the established ARDS Network. Our faculty will provide biostatistical expertise, collaborative assistance in study and protocol design, interim and final analyses, study implementation and coordination, tracking and delivery methods for study drugs and biological specimens, data collection and management, and assistance with dissemination of result, including presentations and publications. Finally, we will provide leadership and expertise to develop and implement detailed, adequately explicit protocols that provide bedside decision-support of network studies, using currently operational electronic tools (Utah Clinical Trial Toolbox).
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