SDTM Example.Subject Inclusion/Exclusion

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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SDTM Example.Subject Inclusion/Exclusion