The national Study to Explore Early Development (Seed) is a multi-year multi-site autism study of several thousand families which commenced enrollment December 2007. SEED will be the largest study to date elucidating the etiology of autism in the
• Implement a secure, centralized, web-based, automated workflow system to improve study quality by standardizing workflows and processes across all study sites and providing end-to-end data management.
• Assess the performance of the CIS.
Use Case Analysis identified the functional requirements. Workflow automation is driven by individual- and role-based dynamic task lists and a flexible event generation system. An Entity-Attribute-Value data collector provides rapid deployment of forms and phone interviews (CATI), meta-data and codebook management. Integration with Internet System for Assessing Autistic Children (ISAAC, Autism Speaks) supports data collection of copyrighted instruments and automated scoring. Personally identifying information is encrypted in the database. Internet communications are encrypted.
CIS supports all study activities: batch import, subject recruitment tracing and tracking, mailings, incentives, reimbursements, barcodes, data entry (double-data entry and CATI), instrument scoring, biosample management, medical record abstraction and request tracking, scheduling, QC workflows, core laboratory integration, data management tools, and many study management and QC reports. Over 25,000 study data elements are now captured in the CIS. Metrics detailing the CIS performance over the first 5 months of study production are presented.
The workflow-oriented CIS represents a modern multi-site study information system that enforces standardized study procedures with the expectation of improved data quality and consistent protocol execution.
Sponsor: Centers for Disease Control and Prevention