This article provides a good example for documenting study subject site transfers, using existing SDTMIG domains and minimal supplemental qualifiers. Originally modeled for COVID studies, this approach could be used any time a study subject change sites during their participation in the study.
Findings results as originally collected may not be review ready for a variety of reasons, so SDTM has a variable, --ORRES, for the result as originally collected, and another variable, --STRESC, for the result in ready-for-review form.
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.