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 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 sponsor assigned a sponsor-defined number to each criteria from the study protocol.     

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.

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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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