DATA COORDINATING CENTER FOR AUTISM & OTHER DEVELOPMENTAL DISABILITIES: SEED I&II

DESCRIPTION (provided by applicant): 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.