SDTM IG 3.4: SR, OE, LB Domain Expansion, and Revised SUPPDS Assumptions
SDTM IG 3.4: SR, OE, LB Expansion, and Revised SUPPDS Assumptions | StudySAS Blog StudySAS Blog | SDTM Programming | Regulatory Submissions | SDTM IG v3.4 Deep Dive Series SDTM IG 3.4 was published by CDISC in July 2022 alongside SDTM v2.0. [1] This post focuses on what actually changes programming and submission behavior — written for SDTM programmers and submission leads. If you have been working from 3.2 or 3.3, several of these changes will require updates to domain routing logic, controlled terminology mappings, Define.xml metadata, and SUPPDS population rules that have been stable in company standards for years. This post examines four areas where working programmers face concrete re-mapping decisions: the SR domain and how the IS scope expansion in 3.4 redraws its boundaries, the OE domain as the post-MO home for ophthalmic data, the restructured LB with confirmed new variables and a substantially narrowed scope, and the SUPPDS assumptions v3.4 quietly rewr...