| Order | Question Text | Prompt | CRF Case Report Form Completion Instructions | Type | CDASH Collection Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | What was the medication name? | Medication |
| CMTRT | CMCAT |
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| NICOTINE REPLACEMENT THERAPY: DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
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| 2 |
| Pre-Specified Intervention |
| CMPRESP | CMSCAT |
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| LAST ATTEMPTED USE WITH THIS MEDICATION |
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| 3 | Did the subject previously use medications to reduce nicotine dependency? | Any Medications Taken For Nicotine Dependency | Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependency | CMOCCUR | CMTRT |
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| 4 | How many times did the subject attempt to use a medication to reduce nicotine dependency. | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use a medication to reduce nicotine dependency | FAORRES | CMDUR |
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| 5 | What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medication the subject used to reduce nicotine dependency. | FACAT | CMDUR |
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| DAYS; MONTHS; YEARS |
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| 6 | What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medication the subject used to reduce nicotine dependency. | CMCAT | CMCAT |
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| NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;
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| 7 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | CMSCAT |
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| LAST ATTEMPTED USE WITH THIS MEDICATION |
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| 8 | What was the name of the medication the subject used to reduce nicotine dependency?
| Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | CMTRT | CMTRT |
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| 9 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | CMCDUR | CMDUR |
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| 10 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | CMCDURU | CMDUR |
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| DAYS; MONTHS; YEARS |
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