Data access and management in the National Children's Study

The National Children's Study (NCS) includes investigation of basic mechanisms of developmental disorders and environmental factors, adverse and protective, that influence health and development processes where environment is defined broadly as physical, chemical, biological, and psychosocial factors. To achieve these objectives a multistage, clustered probability sample design for 100,000 children was developed to ensure that the exposure-outcome relationships identified apply to all of the children in the United States. The probability sample and cluster design provide a means to capture the wide range of exposures with different, often unknown, distributions across the population in the communities selected for study. The size and scope of the study poses considerable and unique challenges for sample collection, data storage, and data analysis. This is addressed through development of a sample management system that governs the site visit structure and content for each study visit and an information management system that tracks samples that are collected and shipped to the NCS repository or to analytical laboratories for analysis. Data are configured with varying levels of specificity such that they can be made available to NCS staff, investigators and the scientific community. The intent is to make the data widely available to stimulate and foster additional more focused adjunct studies that will enable the NCS to serve as a dynamic research platform for children's health investigations.