Data Coordination and Analyses Center for the Community and Child Health Network

DESCRIPTION (provided by applicant): The National Institute of Child Health and Human Development (NICHD) announced its intention (RFA- HD-06-001) to establish a Data Coordination and Analyses Center (DCAC) for the Community and Child Health Network (CCHN). The CCHN will comprise a cooperative agreement among the NICHD, three-to-five Clinical Research Sites (CRSs), and one DCAC. The CCHN will have a Steering Committee (SC) and a Data and Safety Monitoring Board (DSMB). Phase I of the CCHN is near completion and Phase II will consist of a cohort study with 4,000-5,000 participants in the perinatal period who will be followed until their next pregnancies. The CCHN will screen and recruit participants, measure social and biological indicators, and assess outcome variables in the mothers and infants. The Department of Health Evaluation Sciences (DHES) at The Pennsylvania State University College of Medicine proposes to serve as the DCAC for the CCHN. The DCAC will pursue five specific aims to enhance the effectiveness of the CCHN: (1) provide statistical leadership and scientific coordination in the areas of trial design, conduct, analysis, presentations, and publications;(2) establish and maintain the CCHN computer network and websites, one for the general public and a password-protected, secure site for CCHN members;(3) design and maintain the CCHN data management system that relies on a web-based system;coordinate and track CCHN biological specimens;(4) develop and maintain the CCHN data quality assurance and monitoring program to ensure the highest quality data possible;(5) provide project management and administrative support to render smooth and efficient operations in the CCHN. Dr. Chinchilli, the proposed Principal Investigator (principal investigator) of the CCHN DCAC, has extensive experience as the principal investigator of two data coordinating centers (DCCs) for clinical research networks funded by the National Heart, Lung, and Blood Institute (NHLBI), namely, the Asthma Clinical Research Network and the Childhood Asthma Research and Education Network. Because DHES has successfully pioneered many approaches for DCC activities in a clinical research network, the NHLBI Division of Lung Diseases enlisted DHES to train the awardees of the DCCs for two other clinical research networks that it recently formed. Dr. Chinchilli's Co- Investigators for the DCAC include faculty members with additional experience in pediatric statistical issues (Dr. Shaffer), statistical modeling of social and behavioral sciences data (Dr. Rovine), statistical genetics (Dr. Liu), pediatric research (Dr. Paul), adverse pregnancy outcomes (Dr. Weisman), and disparities in children's health (Dr. Hillemeier). In addition, the Penn State Survey Research Center and the Population Research Institute will provide expertise on computer-assisted personal interviewing and geocoding data, respectively.