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

CDASH DS Metadata Specifications

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What was the category of the disposition?	Disposition Category	If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended.	Text	DSCAT	DSCAT		(DSCAT)		DISPOSITION EVENT
2	What is the trial epoch for this disposition event?	Epoch	Select the study epoch for which disposition is being recorded.	Text	EPOCH	EPOCH		(EPOCH)	SCREENING; PRODUCT EXPOSURE;  FOLLOW-UP;
3	What was the completion/discontinuation date?	Completion/Discontinuation Date	Record the date that the subject completed the study or study period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued.	Date	DSSTDAT	DSSTDTC
4	What was the subject's status?	Status	Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation.	Text	DSDECOD	DSDECOD		(TNCOMPLT	COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; PROTOCOL DEVIATION; SCREEN FAILURE; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHER.
5	What was the verbatim reason for the subject status?	Specify	If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason.	Text	DSTERM	DSTERM
6	Will the subject continue into the next epoch?	Continue	Record if the subject will be continuing to the next study period of this study.	Text			NOT SUBMITTED	(NY)	No; Yes
7	What is the next epoch the subject will continue to enter?	Next Epoch	Record the planned subsequent study epoch in which the subject intends to participate.	Text			NOT SUBMITTED	(EPOCH)	PRODUCT EXPOSURE; FOLLOW-UP.

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).

ie.xpt

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

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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