| Metadataspec |
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| 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 is the category for the medication? | Concomitant Medication Category |
| CMCAT | CMCAT |
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| SMOKING CESSATION PRODUCT |
| | 2 | Were any smoking cessation products taken? | Any Smoking Cessation Products Taken | Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF. | CMOCCUR | CMOCCUR | CMOCCUR; CMPRESP | (NY) | Yes; No |
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For each smoking cessation product. If multiple other products are used, create a row for each other product. | Metadataspec |
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| Order | Question Text | Prompt | CRF Completion Instructions | CDASH Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 3 | What is the category for the medication? | Concomitant Medication Category |
| CMCAT | CMCAT |
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| SMOKING CESSATION PRODUCT | | 4 | Were any smoking cessation products taken? | Any Smoking Cessation Products Taken | Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF. | CMOCCUR | CMOCCUR | CMOCCUR; CMPRESP | (NY) | Yes; No |
| | 5 | What was the smoking cessation product used? | Smoking Cessation Product | Select the smoking cessation product. | CMTRT | CMTRT | CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL. |
| NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER |
| | 6 | Was the smoking cessation product used? | Smoking Cessation Product Used | For each product indicate if the product was used. | CMOCCUR | CMOCCUR | CMOCCUR |
| Yes No |
| | 7 | What was the name of the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of product previously used. | CMTRTOT | CMTRT |
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| | 8 | Was the smoking cessation product discontinued due to an adverse experience? | Reason Smoking Cessation Product Discontinued | Indicate if the product was discontinued due to an Adverse Experience | CMCRSDIS | CMRSDISC | If Yes then CMRSDISC = "ADVERSE EXPERIENCE" | (NY) | Yes; No |
| | 9 | What was the last date the product was used? | Last Date Smoking Cessation Product Used | Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded. | CMENDAT | CMENDTC |
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