In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance:
- Using SDTM-specified variable labels for all standard domains
The SDS team members (who develop the SDTM and SDTMIG) found that validation software often returned errors or warnings when a variable label did not match the SDTMIG variable label, character for character. Slight typographical variations on SDTMIG-specified variable labels do not change the meaning or usefulness of variable labels, so in SDTMIG v3.3, this criterion was removed.
For SDTMIG v3.2, variable labels are generally normative except for those that exceed 40 characters in length. This "Error Affecting Conformance" and strategies for coping with it are addressed in the "Errors" tab of the SDTMIG v3.2. For SDTMIG v3.3 and later, variable labels are not normative, but variable labels should still reflect the same meaning as the SDTMIG variable label.