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titleCDASH CM Metadata Specifications

Section 1 

Metadataspec
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category for the medication?Concomitant Medication Category
TextCMCAT



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.TextCMOCCURCMOCCUR; 
(NY)No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  

Metadataspec
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
3What was the smoking cessation product used?Smoking Cessation ProductSelect the smoking cessation product.TextCMTRTCMTRTCMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    


NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4

Did the subject previously use the selected medication/product for smoking cessation?

Smoking Cessation Product UsedIndicate if the subject had used the selected smoking cessation productTextCMOCCURCMOCCUR
(NY)No; Yes
5

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

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



6Was the smoking cessation product discontinued due to an adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to an Adverse ExperienceTextCMRSDISCCMRSDISCIf Yes then CMRSDISC = "ADVERSE EXPERIENCE"(NY)No:Yes:
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. DateCMENDAT CMENDTC