Pediatric Heart network DCC

点击翻译按钮获取中文摘要

DESCRIPTION (provided by applicant): New England Research Institutes, Inc. (NERI) is applying to continue its 10-year role as the Data Coordinating Center (DCC) for the Pediatric Heart Network (PHN). The PHN will continue as a cooperative network of up to 8 Clinical Centers, 15 auxiliary sites, a DCC, a Network Chair, and NHLBI Project Scientists. The objectives of the PHN are to 1) provide an infrastructure for multi-center collaborative clinical research, and 2) to evaluate diagnostic, medical, interventional, and surgical therapies for congenital heart defects, inflammatory heart disease, heart muscle disease, and arrhythmias. As the DCC, NERI will continue to provide scientific and logistical support for the next cycle of the Network, with key responsibilities and functions for leadership in study design and statistics, overall study coordination and management of data acquisition; leadership in development activities for bioinformatics infrastructure and tools; electronic information and data systems; logistical and support services; and management and distribution of Network funds. A multiple PI leadership plan is proposed to continue the leadership roles shared by Dr. Sleeper (Clinical and Statistical Science) and Dr. Tennstedt (Network Operations), with clearly delineated roles and responsibilities for leading and directing the DCC, intellectually and operationally. Importantly, the DCC staff will be organized to include a Network Manager who is also the Manager for the NHLBI Bench to Bassinet Program. This will position the DCC to facilitate integration of the PHN as the clinical trials component of the B2B Program.