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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

CMTRT

What was the medication name?

Medication

CMTRT

CMCAT

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;

2

CMPRESP

		Pre-Specified Intervention		CMPRESP	CMSCAT				LAST ATTEMPTED USE WITH THIS MEDICATION
3

CMOCCUR

	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
4

FAORRES

	How many times did the subject attempt to use a medicaiton to reduce nicotine dependency	Times the Subject Attempted to Reduce Nicotine Dependency	Record the number of times a subject attempted to use a medicaiton to reduce nicotine dependency	FAORRES	CMDUR
5

FACAT

	What is the category of the medication the subject used to attempt to reduce nicotine dependency?	Medication Category	Record the type of medicaiton the subject used to reduce nicotine dependency.	FACAT	CMDUR			DAYS; MONTHS; YEARS
6

CMCAT

What is the category of the medication the subject used to attempt to reduce nicotine dependency?

Medication Category

Record the type of medicaiton the subject used to reduce nicotine dependency.

CMCAT

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;

7

CMSCAT

	What is the subcategory for the medication?	Medication Subcategory	Record the medication subcategory, if not pre-printed on the CRF.	CMSCAT	CMSCAT				LAST ATTEMPTED USE WITH THIS MEDICATION
8

CMTRT

	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
9

CMCDUR

	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
10

CMCDURU

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

DAYS; MONTHS; YEARS

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