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There are 2 sections in this example. The questions in the first section focus on whether any smoking cessation product is used, and the questions in the second section collect each individual product used. . For each smoking cessation product. If multiple other products are used, create a row for each other product. 

OrderQuestion TextPromptCRF Completion InstructionsCDASH Variable Name SDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated Value
1What is the category for the medication?Concomitant Medication Category
CMCATCMCAT


SMOKING CESSATION PRODUCT
2Were 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.CMOCCURCMOCCURCMOCCUR;CMPRESP(NY)Yes; No
3What was the smoking cessation product used?Smoking Cessation ProductSelect the smoking cessation product.CMTRTCMTRTCMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    

NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER


4

Was the smoking cessation product used? 

Smoking Cessation Product UsedFor each product indicate if the product was used.CMOCCURCMOCCURCMOCCUR
Yes No
5

What was the name of the other smoking cessation product used? 

Smoking Cessation Product OtherIndicate the Other type of product previously used. CMTRTOTCMTRT



6Was the smoking cessation product discontinued due to a  adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to a Adverse ExperienceCMCRSDISCMRSDISCIf Yes then CMRSDISC = "ADVERSE Experience"(NY)Yes; No
7What 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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