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>

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	Query Display	List Style	Hidden
1	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

For each product previously taken record the appropriate details below.

	Concomitant Medication Category CMCAT Hidden/pre-populated	SMOKING CESSATION PRODUCT
Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line.	What was the Smoking Cessation medication? CMTRT
Indicate the Other type of smoking cessation products previously used.	What was the name of the other smoking cessation product used? CMTRTOT CMTRT	_________________
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? CMENDTC	Yes, No

.

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	CMTRT	What was the Smoking Cessation medication?	Smoking Cessation Product	Indicate the type of smoking cessation products previously used. For each product type previously used complete a new line.	Text	CMTRT			Nicotine Patches; Nicotine Gum; Nicotine Lozenge; Nicotine Inhaler; Chantix; Zyban ; Other
3	CMTRTOT	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of smoking cessation products previously used.	Text	CMTRT
4	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
5	CMENDTC	Was the product used in the last 14 days?				CMENDTC			Yes, No

Thsi is the SDTM date for the date collected above.

Rows 1,4-6 :	The subject reported that they had not previously used the specified smoking cessation product.
Row 3:	The subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended 14 prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case i2020-02-12. CMENRTPT indicates the usage ended prior to the date in CMENTPT. .
Row 4	The subject reported using Nicotine Gum. This gum was used within 14 days of the date of collection. Since, the last date of use is not known CMENDTC describe the beginning and the end of the interval of uncertainty. The dates are separate them with a solidus, as shown in the following table.

Row Captions Debug Message

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cm.xpt

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMOCCOR	CMDTC	CMENDTC	CMENTPT	CMENRTPT
1	ABC	CM	ABC-0001	1	NICOTINE PATCH	N	2020-02-15
2	ABC	CM	ABC-0001	2	NICOTINE GUM	Y	2020-02-15	2020-02-02/2003-02-15
3	ABC	CM	ABC-0001	3	NICOTINE LO	Y	2020-02-15		2020-02-12	PRIOR
4	ABC	CM	ABC-0001	4	NICOTINE INHALER	N	2020-02-15	2004-01-07
5	ABC	CM	ABC-0001	5	Chantix	N	2020-02-15	2004-01-07
6	ABC	CM	ABC-0001	6	Zyban	N	2020-02-15	2004-01-09

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Concomitant Medications - Prior Use of Smoking Cessation Products