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title	CDASH CM Metadata Specifications

Metadataspec

Order

CDASH Variable Name

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
1

CMCAT

	What is the category for the medication?	Concomitant Medication Category		CMCAT	CMCAT				SMOKING CESSATION PRODUCT
2

CMOCCUR

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
3

CMTRT

	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
4

CMOCCUR

Was the smoking cessation product used?	Smoking Cessation Product Used	For each product indicate if the product was used.	CMOCCUR	CMOCCUR	CMOCCUR		Yes;No
5

CMTRTOT

	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
6

CMCRSDIS

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

CMENDAT

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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