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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 The reason why a product was discontinued and any use in the last 14 days was of interest. .

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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 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 This is the SDTM date for the date collected above.

Dataset wrap

Name	cm

Rowcaps

Rows Row 1,4-6 :	The subject Show the subject reported that they had not previously used the specified any smoking cessation product.
Row 2:	Shows 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 3:	The Shows subject reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15. This usage was ended at least 14 days prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case i20202020-02-12. CMENRTPT indicates the usage ended prior to the date in CMENTPT. .
Row Rows 4-6	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 tableShows the subject used these products . The subject discontinued Zyban for an adverse event.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMOCCOR	CMPRESP	CMRSDISC	CMDTC	CMENDTC	CMENTPT	CMENRTPT
1	ABC	CM	ABCXYZ-0001	1NICOTINE PATCH	SMOKING CESSATION PRODUCT		N			2020-0201-1505
2	ABC	CM	ABC-0001	23	NICOTINE GUM	SMOKING CESSATION PRODUCT		Y		2020-02-15	2020-02-02/2003-02-15
3	ABC	CM	ABC-0001	34	NICOTINE LOLOZENGE	SMOKING CESSATION PRODUCT		Y		2020-02-15		2020-02-12	PRIOR
4	ABC	CM	ABC-00010003	41	NICOTINE INHALER	N	SMOKING CESSATION PRODUCT		Y		2021-04-162020-02-15	2004-01-07
5	ABC	CM	ABC-00010003	52	Chantix	N	SMOKING CESSATION PRODUCT		Y		2021-04-162020-02-15	2004-01-07
6	ABC	CM	ABC-00010003	63	Zyban	N		SMOKING CESSATION PRODUCT		Y	CMRSDISC	2021-04-162020-02-15	2004-01-09

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