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Showing posts with the label LB Unit Conversion in SDTM

7 Mistakes in LB Unit Conversion That Still Show Up in SDTM

7 Mistakes in LB Unit Conversion That Still Show Up in SDTM | StudySAS StudySAS Blog | SDTM Programming | Regulatory Submissions April 2026  |  LBORRES · LBSTRESC · LBSTRESN · FDA · PMDA · SAS LB unit conversion is not hard to understand. The variable definitions are clear. The model is well-documented. And yet unit-related problems remain among the most common issues in SDTM submissions — not because teams do not know the rules, but because the failures are quiet. Nothing crashes. The dataset looks valid. Pinnacle 21 returns a clean report. Then a reviewer runs a simple cross-tabulation and finds creatinine flagged HIGH at a value that belongs well within the normal range — because the reference range was never converted to match the standard unit. This post is a close look at seven implementation mistakes, each with enough context and worked examples to make the failure mode visible before it reaches a submission. LBORRES is what was collected. Verbatim...