| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | IEYN | 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. | CMCAT | IEYN | 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.NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; |
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| 2 | IECAT | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion. | IECAT | What was the category of the criterion? | Criterion Type | Record whether the criterion exception was Inclusion or Exclusion.CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION |
| 3 | IETESTCD | 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. | IETESTCD | 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.CMTRT |
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