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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
<NY codelist>
Record whether the criterion exception was Inclusion or Exclusion.What was the category of the criterion?
IECAT
<IECAT codelist>
If the subject was not eligible, record the identifying code for each criterion that was an exception.
IETESTCD
_________________
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
IEYN1Were 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.TextN/A
(NY)Yes; No

radio
IECAT2What was the category of the criterion?Criterion TypeRecord whether the criterion exception was Inclusion or Exclusion.TextIECAT
(IECAT)Inclusion; Exclusion

radio
IETESTCD3What 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.TextIETESTCD






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

ie.xpt

RowSTUDYIDDOMAINUSUBJIDIESEQIESPIDIETESTCDIETESTIECATIEORRESIESTRESCVISITNUMVISITVISITDYIEDTCIEDY
1XYZIEXYZ-0007117EXCL17Ventricular RateEXCLUSIONYY1WEEK -8-561999-01-10-58
2XYZIEXYZ-000723INCL03Acceptable mammogram from local radiologist?INCLUSIONNN1WEEK -8-561999-01-10-58
3XYZIEXYZ-004713INCL03Acceptable mammogram from local radiologist?INCLUSIONNN1WEEK -8-561999-01-12-56
4XYZIEXYZ-009613INCL03Acceptable mammogram from local radiologist?INCLUSIONNN1WEEK -8-561999-01-13-55
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