CDASH Example.Medications Used for Nicotine Dependency

This is an example CRF that collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The applicant only collected details on the last attempt to reduce nicotine dependency for each type of product used. In order to save space, some of the permissible values are only shown in the metadata specifications.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What was the medically recognized product name?	Medication		Text	CMTRTC	CMTRT				DRUG USED IN NICOTINE DEPENDENCE
2		Pre-Specified Intervention		Text	CMPRESP	CMPRESP				Y
3	Did the subject previously use medically recognized products to reduce nicotine dependency?	Any Medically Rrecognized Products Taken For Nicotine Dependency	Indicate if the subject had used any medically recognized products to attempt to reduce nicotine dependency	Text	CMOCCUR	CMOCCUR		(NY)	No;Yes;Not Done
4	How many times did the subject attempt to use a use medically recognized products to reduce nicotine dependency	Times the Subject Attempted to Reduce Nicotine Dependency	Record the number of times a subject attempted to use medically recognized products to reduce nicotine dependency	Text	FAORRES	FAORRES	FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "
5		Category		Text	FACAT	FACAT				ATTEMPTS TO REDUCE NICOTINE DEPENDENCE

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Controlled Terminology CodeList Name	Permissible Values
6	What is the category of the medication/product the subject used to attempt to reduce nicotine dependency?	Medication		Text	CMTRT	CMCAT	NICOTINE REPLACEMENT THERAPY: DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS
7	What is the medication/product subcategory, if not pre-printed on the CRF.	Subcategory	Applicant Defined	Text	CMSCAT	CMSCAT		LAST ATTEMPTED USE WITH THIS MEDICATION
8	What was the name of the medication/product the subject used to reduce nicotine dependency?	Medication	Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name.	Text	CMTRT	CMTRT
9	What was the duration of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration	Provide the duration of the medication/product used.	Text	CMCDUR	CMDUR
10	What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt?	Collected Duration Unit	Select the appropriate duration unit of the medication/product used.	Text	CMCDURU	CMDUR	DAYS; MONTHS; YEARS

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CDASH Example.Medications Used for Nicotine Dependency