DEFINITION : The Inclusion/Exclusion Criteria (IE) domain captures whether a subject meets or does not meet the predefined criteria for participation in the study.

PURPOSE : To document which inclusion or exclusion criteria a subject met or did not meet at the start of the study.

STRUCTURE : One record per inclusion/exclusion criterion not met per subject

TOPIC : IETESTCD

KEY VARIABLES : STUDYID, USUBJID, IETESTCD