Article
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.
Article
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.
Article
SDTM v2.0 is the first major release since the model's original publication in 2004. Among many modifications and updates, the most significant change is that variable metadata is represented in a new structure.
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