Data Coordinating Center for the NHLBI Asthma Network (AsthmaNet)

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DESCRIPTION (provided by applicant): Asthma affects more than 22 million persons and it is one ofthe most common chronic diseases of childhood. The NHLBI is establishing AsthmaNet, a clinical research network that will develop and conduct multiple clinical trials to address important clinical management questions and new approaches to treating asthma across the lifetime. The NHLBI's strategic plan for clinical research networks includes maintaining a focus on improving clinical care; allowing flexibility in research designed to advance the development of novel therapies and translational research; promoting scientific exchange, use of resources and standardization across networks; and facilitating rapid dissemination of research findings to the medical community. AsthmaNet will include multiple Clinical Centers (CCs) and one Data Coordinating Center (DCC). The Department of Public Health Sciences (DPHS) at The Pennsylvania State University College of Medicine proposes to serve as the DCC for AsthmaNet. The DCC will have a central role in all stages of AsthmaNet studies from design and development to implementation, analysis, and dissemination of results. Specifically, DPHS will; (1) provide statistical and data analysis expertise for all studies, including statistical design and sample size estimation; (2) establish and manage the study databases; (3) establish and manage a communication systems; (4) provide scientific coordination for the CCs that includes collaborating with the AsthmaNet investigators on protocol development and implementation, formatting data collection forms for each protocol, preparing and leading training sessions, establishing certification criteria for AsthmaNet procedures, and writing the manuals of operations; (5) monitor and evaluate protocol execution and quality of data and provide reports to NHLBI; (6) provide project management and administrative support, including arranging meetings and telephone conference for all AsthmaNet related committees; (7) establish, maintain, and provide oversight to subcontracts; (8) collaborate with the NHLBI and other networks involved in pulmonary research to standardize common data elements and practices to increase operational efficiency; (9) manage NHLBI protocol funds and distribute them to the CCs; and (10) prepare public-use files for archiving and sharing study results, disseminating research findings, and sharing resources such as study manuals and case-report forms.