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The Inclusion/Exclusion Criteria (IE) domain is a findings domain that contains 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. The TI domain is not subject oriented.       

Example

This is an example CRF used to collect subject inclusion/exclusion criteria. 

Section 1 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were all eligibility criteria met?Met CriteriaRecord 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.TextIEYN
Not Submitted


Section 2

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What was the category of the criterion?Criterion TypeRecord whether the criterion exception was Inclusion or Exclusion.TextIECATIECAT



3What was the identifier of the inclusion criterion the subject did not meet or the exclusion criterion the subject met?Exception Criterion IdentifierIf the subject was not eligible, record the identifying code for each criterion that was an exception.TextIETESTCDIETESTCD



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

ie.xpt

RowSTUDYIDDOMAINUSUBJIDIESEQIESPIDIETESTCDIETESTIECATIEORRESIESTRESCVISITNUMVISITVISITDYIEDTCIEDY
1XYZIEXYZ-0007117EXCL17Ventricular RateEXCLUSIONYY1WEEK -8-561999-01-10-58
2XYZIEXYZ-000723INCL03Laboratory Test results within normal rangeINCLUSIONNN1WEEK -8-561999-01-10-58
3XYZIEXYZ-004713INCL03Laboratory Test results within normal rangeINCLUSIONNN1WEEK -8-561999-01-12-56
4XYZIEXYZ-009613INCL03Laboratory Test results within normal rangeINCLUSIONNN1WEEK -8-561999-01-13-55
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