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Record Qualifier v.s. Variable Qualifier

If you think it’s clear enough to differentiate record qualifier from variable qualifier as they were defined (in CDISC SDTM Version 1.3):

Record Qualifiers define additional attributes of the observation record as a whole (rather than describing a particular variable within a record). Examples include –REASND, AESLIFE, and all other SAE flag variables in the AE domain; AGE, SEX, and RACE in the DM domain; and –BLFL, –POS, –LOC, –SPEC, and –NAM in a Findings domain

Variable Qualifiers are used to further modify or describe a specific variable within an observation and are only meaningful in the context of the variable they qualify. Examples include –ORRESU, –ORNRHI, and –ORNRLO, all of which are Variable Qualifiers of –ORRES; and –DOSU, which is a Variable Qualifier of –DOSE.

take a look at this table, where

  • Role in column C comes from SDTMIG V3.1.3
  • Role in column E comes from SDTM V1.3


It is unavoidable for such systemic confusion among record qualifier and variable qualifier. A variable is a variable, and I don’t think it’s even possible to capture such subtle differences.