Conference: PharmaSUG US 2026
Date: May 31 - June 3, 2026
Location: Boston, MA
Booth: 202 and 204
Hear key learning objectives and insights from our technical experts
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.
Watch this short video and see how to achieve submission ready conformance with Pinnacle 21
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