Page History

...

The Findings About Events or Interventions (FA) domain was used to represent the assessment of craving. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the guide. In this example, a FACE dataset was used, indicating these data are findings about clinical events. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are considered findings about the clinical event.  A parent record in the Clinical Events (CE) domain is not required.

...