ACDM

Author: Julie Ann Hood

High-quality, CDISC-compliant SDTM datasets are the result of coordinated teamwork, rather than individual effort. Modern clinical trials rely on a multidisciplinary “SDTM Squad” made up of Data Managers, Standards Managers, Clinical Programmers, and Biostatisticians, each contributing specialized expertise to produce submission-ready data. While these roles originate from different domains, they share a foundational understanding of CDISC standards – whether through SDTM variables on aCRFs, CDASH-based EDC systems, or standardized specifications – which helps break down silos and enables more collaborative, efficient workflows.

As standards evolve and expectations for speed, accuracy, and AI-assisted processes increase, there is no single correct approach to SDTM creation, but there are smarter ones. By recognizing and leveraging the strengths of each role, teams can redesign workflows, distribute responsibilities more effectively, and innovate.

This poster highlights the unique skills each role brings, along with emerging AI contributions, to demonstrate how strategic collaboration can accelerate SDTM creation while maintaining regulatory compliance.