Concomitant Medications - Prior Use of Smoking Cessation Products

This is an example CRF used to collect information on prior use of smoking cessation products. The specific type of non-pharmaceutical smoking cessation product was not of interest. The reason why a product was discontinued and any use in the last 14 days was of interest. .

Indicate if the subject took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF.	Were any smoking cessation products taken? CMYN Not Submitted	Yes No <NY codelist>
Check all the Smoking Cessation Products previously used. Cessation product used. For each product previously complete the following i	What was the Smoking Cessation medication? CMTRT(n) CMTRT
	What was the name of the other smoking cessation product used? CMTRTOT CMTRT	_________________

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	Controlled Terminology Code List Name	Permissible Values
2	CMYN	Were any smoking cessation products taken?	Any Smoking Cessation Products	Indicate if the subject took any smoking cessation products If Yes, include the appropriate details where indicated on the CRF.	Text	N/A	(NY)	Yes; No
4	CMTRT(n)	What was the Smoking Cessation medication?	Smoking Cessation Product	Check all the Smoking Cessation Products previously used. Cessation product used. For each product previously complete the following i	Text	CMTRT		Nicotine Patches; Nicotine Gum; Nicotine Lozenge; Nicotine Inhaler; Chantix; Zyban ; Other
5	CMTRTOT	What was the name of the other smoking cessation product used?			Text	CMTRT

	Concomitant Medication Category CMCAT Hidden/pre-populated	SMOKING CESSATION PRODUCT
Indicate if the smoking cessation product was discontinued due to a Adverse Event	Was the smoking cessation products discontinued due to a adverse event ? CMCRSDIS If Yes then CMRSDISC = "ADVERSE EVENT"	Yes No <NY codelist>
	Was the product used in the last 14 days : CM CMENDTC	Yes, No

For each product previously taken record the appropriate details below.

Order	CDASH Variable	Question Text	Prompt	CRF Completion Instructions	Type	SDTMIG Target	SDTMIG Target Mapping	Controlled Terminology Code List Name	Permissible Values	Pre-Populated Value	Hidden
1	CMCAT	What is the category for the medication?	Concomitant Medication Category	Record the medication category, if not pre-printed on the CRF.	Text	CMCAT				SMOKING CESSATION PRODUCT	Yes
2	CMCRSDIS	Was the smoking cessation products discontinued due to a adverse event ?	Reason Smoking Cessation Product Discontinued	Indicate if the smoking cessation product was discontinued due to a Adverse Event	Text	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EVENT"	(NY)	Yes; No
3	CM	Was the product used in the last 14 days :				CMENDTC			Yes, No

Represent that end sometime between the date of collection , and 14 days prior IF DTC = 2020-02-15 then ENDTC= (e.g 2020-02-02/2003-02-15 )

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Concomitant Medications - Prior Use of Smoking Cessation Products