CDISC EU 2026

Presenter: Kristin Kelly

The imminent release of the CDISC SDTMIG v4.0 / SDTM v3.0 represents a pivotal moment for SDTM standards. As a major version update, it introduces significant changes that sponsors should begin preparing for now.

Key updates include support for Multiple Subject Instances (MSI), the transition from SUPPQUAL to Non-Standard Variables (NSVs), and metadata restructuring aligned with SDTM Model v3.0. The –BLFL variable has been removed and Sections 1–4, which provide guidance across SDTM domains, have been reorganized for improved clarity and usability.

Variables are now organized into Variable Groups, enhancing structure and interpretation. New domains such as Event Adjudication (EA) and Gastrointestinal Findings (GI) further expand the ability to handle more types of data. Also noteworthy are updates to the Protocol Deviations (DV) domain and specimen-based Findings domains.

This paper will explore what’s new in SDTMIG v4.0 and provide practical guidance to help sponsors navigate this era of transition.

Presenter: Julie Ann Hood

Behind every high-quality, CDISC-compliant SDTM dataset lies a team, not of ordinary professionals, but of data-driven heroes, each with their own unique skillsets and battle-tested expertise. In today’s clinical trials, creating and validating submission-ready datasets is rarely a solo mission. It’s a full-scale, multi-role operation that calls upon the powers of Data Managers, Standards Managers, Clinical Programmers, and Biostatisticians, each bringing something special to the fight for clean, conformant data.

Our heroes may come from different domains, but they share a common trait: a working knowledge of CDISC standards. Whether it’s SDTM variables on an aCRF, CDASH-structured EDC systems, or routine exposure to standardized specs, each role is already familiar with the tools of the trade. This foundational knowledge becomes their secret weapon: breaking down long-standing silos and enabling smarter, more collaborative workflows than ever before.

In a world of evolving standards, AI-assisted processes, and increasing expectations for speed and accuracy, the path to submission success isn’t always linear. There’s no single “right way” to create SDTM datasets, but there are more efficient ways. Understanding the strengths of each role opens up opportunities to rethink traditional processes, distribute tasks more effectively, and innovate with workflows that leverage each team member’s unique expertise.

This poster will present our SDTM Squad in full force, outlining the signature skills and superpowers each role brings to the clinical trial data lifecycle, alongside the emerging contributions of AI. From the Data Manager’s deep study knowledge to the Biostatistician’s analytical foresight, and the Standards Manager’s metadata mastery to the Programmer’s precision code, we’ll explore how these abilities combine to form faster, more efficient processes for SDTM dataset creation and validation.

By highlighting the strengths of this dynamic team, we’ll demonstrate that with the right strategy and collaboration, regulatory compliance can be both faster and more heroic.