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In all versions of the SDTMIG through v3.2, the "Conformance" section includes the following as a criterion for conformance:

If your data is based on a general observation class, you can determine the answer to this question by consulting the SDTM. Qualifiers for your general observation class, timing variables, and identifiers can generally be added to the dataset.

The earliest version of the SDTMIG had only one domain for tests on biologic specimens taken from a study subject, the Laboratory Test (LB) domain. SDTMIG v3.4 has 10 domains for specimen-based findings, plus the Biospecimen Events domain.

When an implementer is working how to represent data for a study, they first consult the SDTMIG and SDTM to find the appropriate standard variable. If no appropriate standard variable is found, the SDTMIG directs them to create a supplemental qualifier, also called a non-standard variable.