SDTM Example.Subject Inclusion/Exclusion

This is an example CRF used to collect the subject's eligibility.

Example CRF: Inclusion/Exclusion

Example CRF Completion Instructions

All procedures must be performed and the subject’s eligibility determined within <protocol-specified time period prior to study medication administration>.
(If applicable, include the following instructions) Complete the Inclusion/Exclusion Worksheet as source document by recording a “Yes” or “No” response to each criterion.
Record the criterion identification that was an exception.

Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.	Were all eligibility criteria met? IEYN Not Submitted	Yes No <NY codelist>
Record whether the criterion exception was Inclusion or Exclusion.	What was the category of the criterion? IECAT	Inclusion Exclusion <IECAT codelist>
If the subject was not eligible, record the identifying code for each criterion that was an exception.	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met? IETESTCD	_________________

CDASH Variable	Order	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target Variable	Controlled Terminology Code List Name	Permissible Values	List Style
IEYN	1	Were all eligibility criteria met?	Met Criteria	Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled.	Text	N/A	(NY)	Yes; No	radio
IECAT	2	What was the category of the criterion?	Criterion Type	Record whether the criterion exception was Inclusion or Exclusion.	Text	IECAT	(IECAT)	Inclusion; Exclusion	radio
IETESTCD	3	What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?	Exception Criterion Identifier	If the subject was not eligible, record the identifying code for each criterion that was an exception.	Text	IETESTCD

This is an example of 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.

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	Acceptable mammogram from local radiologist?	INCLUSION	N	N	1	WEEK -8	-56	1999-01-10	-58
3	XYZ	IE	XYZ-0047	1	3	INCL03	Acceptable mammogram from local radiologist?	INCLUSION	N	N	1	WEEK -8	-56	1999-01-12	-56
4	XYZ	IE	XYZ-0096	1	3	INCL03	Acceptable mammogram from local radiologist?	INCLUSION	N	N	1	WEEK -8	-56	1999-01-13	-55

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SDTM Example.Subject Inclusion/Exclusion