When the Guidance for Ongoing Studies Disrupted by COVID-19 was being developed, one of the issues was how to represent subject visits, given that regulators wanted to know about visits that were missed or modified due to the pandemic.
The CDASHIG section "PE - Physical Examination" describes a best practice for collecting physical examination data. Basically, any abnormalities would be recorded as medical history or adverse events, depending on timing whether an exam was performed would be recorded by treating the exam as a procedure.
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.
This example shows a CRF used to collect information on an orchidometer examination.
This example shows data on subject's Diabetic Ketoacidosis during a study.
This example shows data on laboratory results collected for each diabetic ketoacidosis event
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.