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The Inclusion/Exclusion Criteria (IE) domain is a findings Findings domain that contains those criteria that cause the subject to be in violation of the protocol inclusion/exclusion criteria. The trial design domain TI (not shown here; see Section 3.3.1, Trial Design) is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI. This The TI domain is not subject oriented. The TI domain is described in the section on Trial Design Description. The TI domain is not shown.          

Example

Include Page
CDASH Example.Subject DispositionInclusion/Exclusion Criteria
CDASH Example.Subject DispositionInclusion/Exclusion Criteria

Include Page
SDTM Example.Subject Inclusion/Exclusion
SDTM Example.Subject Inclusion/Exclusion

Pagenav