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Description/Overview

The CDASHIG IE domain is recommended for collecting only inclusion/exclusion exceptions. In other words, those criteria that are "not met"; these are the data that are required to be in the SDTMIG IE domain. The CDASHIG IE domain is used to collect failures on or exceptions to the inclusion/exclusion criteria during the screening process before a subject is enrolled in a study. It is not intended to collect protocol deviations or violations that occur after enrollment; protocol deviations are collected using the DV domain.

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