This proposal builds upon the activities and accomplishments funded under Cooperative Agreements U10DD000007 and U01/DD000498 that established a Data Coordinating Center (DCC) for the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE) at Michigan State University (MSU). A research program funded by the Centers for Disease Control and Prevention, CADDRE focuses primarily on the Study to Explore Early Development (SEED), a six-site collaborative study to identify factors that may put children at risk for autism spectrum disorder (ASD). Since 2004, MSU has built and hosted the CADDRE Information System (CIS), a centralized web-based automated-workflow system that supports all of the activities for CADDRE SEED, and has delivered a full spectrum of data center support to sites in Georgia, North Carolina, Maryland, Pennsylvania, Colorado, and California. In June, 2011, the SEED sites were funded for SEED Phase II (SEED-II) for the purpose of enrolling a second cohort, which will double the total number of study children to about 7,000. With the inclusion of parents, nearly 20,000 subjects must be tracked, assessed and followed. SEED-II funding requires that each site undertake analytic studies based on the pooled set of SEED-I data. This requirement makes it mandatory that the CADDRE DCC be able to hit the ground running to facilitate timely execution of the new enrollments in SEED-II, while at the same time providing convenient data access and full support to the rapidly growing number of priority analytic studies that use SEED-I data.
The Specific Aims of the CADDRE DCC focus on the technical elements of data capture and integrity, and on a spectrum of services and capabilities comprehensively supporting the investigators'scientific objectives. Subsumed under these aims are specific fundamental functions and deliverables described in the body of the proposal. These include: (1) Assure data quality and security;(2) Maintain CIS (I&II) application code, with enhancements of functionality as needed;(3) Execute medical coding protocols for approximately 1,000,000 verbatim text study text fields;(4) Maintain adequate staffing levels and capabilities;(5) Maintain information system infrastructure;(6) Provide leadership regarding data confidentiality and security policies;(7) Support study sites, and users broadly;(7) facilitte data sharing, data access for analyses, and data integration requirements;(8) Deliver multi-faceted study communication tools;(9) Contribute to project scientific, executive and analytic decision making;(10) Participate in scientific meetings and publish on informatics contributions to autism research;and (11) Obtain a Federal Authorization to Operate the CIS-II study management system. At the completion of the SEED studies, we expect that the MSU DCC will transform raw SEED data into a scientifically valuable database that is easy to access, understand, and deploy in autism research for many years into the future.
This proposal will continue support of the CADDRE Data Coordinating Center (DCC) at Michigan State University. The DCC provides data management and quality control services to facilitate CDC-sponsored research into the causes of autism, a serious disabling condition that has been estimated to occur in 1 in 110 children in the US. This support is targeted towards the Study to Explore Early Development (SEED), Phases I &II, the largest Federally-funded epidemiology study ever conducted and designed to help identify factors that may put children at risk for autism.