Subject Inclusion/Exclusion Criteria (IE)

The Inclusion/Exclusion Criteria (IE) domain is a 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, is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI . This 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

This is an example SDTM dataset that represents data collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology (EXCLUSION or INCLUSION). IETEST and IETESTCD are defined in the TI domain. The applicant assigned a number to each criteria from the study protocol using the permissible variable IESPID (Applicant-defined Identifier).

Rows 1-2:	Show data for a subject with 2 inclusion/exclusion exceptions.
Rows 3-4:	Show data for 2 other subjects, both of whom failed the same inclusion criterion.

ie.xpt

Row	STUDYID	DOMAIN	USUBJID	IESEQ	IESPID	IETESTCD	IETEST	IECAT	IEORRES	IESTRESC	VISITNUM	VISIT	VISITDY	IEDTC	IEDY
1	XYZ	IE	XYZ-0007	1	17	EXCL17	Ventricular Rate	EXCLUSION	Y	Y	1	WEEK -8	-56	1999-01-10	-58
2	XYZ	IE	XYZ-0007	2	3	INCL03	Laboratory Test results within normal range	INCLUSION	N	N	1	WEEK -8	-56	1999-01-10	-58
3	XYZ	IE	XYZ-0047	1	3	INCL03	Laboratory Test results within normal range	INCLUSION	N	N	1	WEEK -8	-56	1999-01-12	-56
4	XYZ	IE	XYZ-0096	1	3	INCL03	Laboratory Test results within normal range	INCLUSION	N	N	1	WEEK -8	-56	1999-01-13	-55

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Subject Inclusion/Exclusion Criteria (IE)