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These example SDTM datasets represent the data collected on the above CRF.

Dataset wrap

Rowcaps

Rows 1, 3, 7, 9:

Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary.

Rows 2, 4, 5, 6, 8:

Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.

Panel

Modelling of this information needs discussion at ISMT.

Should this be related to SU using FASU,

Should the NRT be recorded in CM, or SU.

How to represent in SUCAT Should SUCAT always be TOBACCO... can Nicotine be used.

Image Removed

Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping Collected with Check all that appy in CDASH.

Current type of smokeless tobacco used, Snuff, Chewing tobacco. Amount Used : Cans/pouches per week, Dips per day Dipping tobacco is a type of finely ground or shredded, moistened smokeless tobacco product. It is commonly and idiomatically known as "dip". Dipping tobacco is used by placing a pinch, or "dip", of tobacco between the lip and the gum (sublabial administration). The act of using it is called dipping.

Other users of tobacco in household

Years of regular smokeless tobacco use

Fagerstrom Test for Nicotine Dependence (FND) The Fagerström Tolerance Questionnaire was developed by Karl-Olov Fagerström. This instrument was modified to the Fagerström Test for Nicotine Dependence by Todd Heatherton, et al. in 1991. The FTND is copyrighted by Taylor and Francis Ltd., but may be reproduced without permission, as available from the source reference (Heatherton, et al., 1991).

Smoking status (self-reported and biochemically validated)

Nicotine Replacement
Therapy (NRT

Pharmaceuticals
other than NRTs

Other
Smoking Cessation aids

What was the name of the product the subject used to attempted to quit smoking?

Smoked tobacco products;

Chewed tobacco products;

Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco)

What was the Nicotine Replacement
Therapy (NRT) used to quit smoking?

Xformpusher

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the category of the substance used?

Substance Use Category

Record the Substance Used category, if not pre-printed on the CRF.

Text

SUCAT

Recreational Drugs

SUYN

2

Age subject began smoking daily

Any Recreational Drugs Used

Indicate if the subject had used any recreational drugs.

Text

N/A

(NY)

Yes; No

SUTRT

3

Average number of cigarettes
smoked per day over the past year

Type of Recreational Drug Used

Record the name of the recreational drug used.

Text

SUTRT

SUNCF

4

Has the subject attempted to quit
with the use of Nicotine Replacement
Therapy (NRT)? List details of NRT
products used in the section

Usage

Check the appropriate box to indicate if the subject currently or formerly used recreational drugs.

Text

SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF

SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER".

(NCF)

Current; Former

Prompt

SUDSTXT

5

Has the subject attempted to quit
with the use of pharmaceuticals
other than NRTs? List details of
other pharmaceuticals used in the
section.

Amount

Indicate the amount of recreational drugs the subject consumes on a regular basis.

Text

SUDOSE; SUDOSTXT

SUDOSFRQ

6

Has the subject attempted to quit
with the use of other smoking
cessation aids? List details of other
smoking cessation aids used in the
ection.

Frequency

Record how often the subject regularly uses recreational drugs.

Text

SUDOSFRQ

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

SUCDUR

7

Has the subject made any other
attempts to quit smoking? List details
of other quit attempts in the
Comments section.

Duration

Provide the duration of the substance use (e.g., how long the subject has smoked).

Text

SUDUR

Prompt

Panel

title	Type of Product Used to Quit Smoking

Xformpusher

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the type of product the subject used to attempted to quit smoking?

Substance Use Category

Record the type of tobacco product used

Text

SUCAT

SUTRT

4

Text

SUTRT

SUDSTXT

5

What was the amount of tobacco product used to quit smoking?

Amount

Indicate the amount of amount of tobacco product used to quit smoking?

Text

SUDOSE; SUDOSTXT

Prompt

SUDUR

6

What was the duration of the tobacco product usage to quit smoking?

Duration

Provide the duration of the substance use

Text

SUDOSFRQ

QD; EVERY WEEK; QM; PA

Prompt

SUCDURU

7

What was the duration unit of the tobacco product used to quit smoking?

Unit

Select the appropriate duration unit of the tobacco product used

Text

SUDUR

DAYS; MONTHS; YEARS

Prompt

SUDOSFRQ

8

What was the frequency of of the tobacco product used to quit smoking

Frequency

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

Panel

title	Tobacco Product Usage

Xformpusher

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUCAT

1

What is the product the subject used to attempted to quit smoking?

Substance Use Category

Record the type of tobacco product used

Text

SUCAT

SUTRT

4

Text

SUTRT

SUDSTXT

5

What was the amount of tobacco product used to quit smoking?

Amount

Indicate the amount of amount of tobacco product used to quit smoking?

Text

SUDOSE; SUDOSTXT

Prompt

SUDUR

6

What was the duration of the tobacco product usage to quit smoking?

Duration

Provide the duration of the substance use

Text

SUDOSFRQ

QD; EVERY WEEK; QM; PA

Prompt

SUCDURU

7

What was the duration unit of the tobacco product used to quit smoking?

Unit

Select the appropriate duration unit of the tobacco product used

Text

SUDUR

DAYS; MONTHS; YEARS

Prompt

SUDOSFRQ

8

What was the frequency of of the tobacco product used to quit smoking

Frequency

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

Dataset wrap

Rowcaps

Row 1:	Subject 1234005 is a 2-pack/day current smoker. “Current” implies that smoking started sometime before the time the question was asked (SUSTTPT = "2006-01-01", SUSTRTPT = "BEFORE") and had not ended as of that date (SUENTTP = "2006-01-01", SUENRTPT = "ONGOING"). See Section 4.4.7, Use of Relative Timing Variables for the use of these variables. Both the beginning and ending reference time points for this question are the date of the assessment.
Row 2:	Subject 1234005 drank 3 cups of coffee on the day of the assessment.
Row 3:	Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:	Subject 1234006 drank tea on the day of the assessment.
Row 5:	Subject 1234006 drank coffee on the day of the assessment.
Row 6:	Subject 1234007 had missing data for the smoking questions; this is indicated by SUOCCUR null and SUSTAT = "NOT DONE". The reason is in SUREASND.
Row 7:	Subject 1234007 also had missing data for all of the caffeine questions.

Dataset2

SUPRESPSUOCCURY or N

Row	STUDYID	DOMAIN	USUBJID	SUSEQCMSEQ	SUTRTCMTRT	SUCATCMCAT	CMSCAT	CMPRESP	SUSTATCMOCCUR	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	CMDTC	CMDURSUENRTPT
1	1234	SUCM	1234005	1	CIGARETTES	TOBACCO	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2	PACK	QD	2006-01-01	BEFORE	2006-01-01	ONGOING	2008-08-08
2	1234	SUCM	1234005	2	COFFEE	CAFFEINE	Y	Y	3	CUP	QD	2006-01-01	NICOTINE PATCH XYZ	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
2006-01-01	3	1234	SUCM	1234006	1	CIGARETTES	TOBACCO	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	1	PACK	QD	2003	2006-03-15	BEFORE	2008-11-12
4	1234	SUCM	1234006	2	TEA	CAFFEINE	Y	Y	1	CUP	QD	2006-03-15	2006-03-15	5	1234	SU	1234006	3	COFFEE	CAFFEINE	Y	Y	2	CUP	QD	2006-03-15	2006-03-15	6	1234	SU	1234007	1	CIGARETTES	TOBACCO	Y	NOT DONE	Subject left office before CRF was completed	7	1234	SU	1234007	2	CAFFEINE	CAFFEINE	Y	NOT DONE	Subject left office before CRF was completed	NICOTINE REPLACEMENT THERAPY	NICOTINE	Y OR N	SMOKELESS CIGARETTES	NICOTINE GUM ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION	P3M
5	1234	CM	1234006	3	NICOTINE LOZENGES ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2W
6	1234	CM	1234006	1	BUPROPION	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P1M
7	1234	CM	1234007	2	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-06-12
8	1234	CM	1234007	3	VARENICLINE	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P40D
9	1234	CM	1234012	1	DRUG USED IN NICOTINE DEPENDENCE			Y	N	2008-03-05

FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.

Dataset wrap

Name	fasu	facm

Rowcaps

Rows 1, 6, 11:

Rows 2-5, 7-10, 12-15:

Dataset2

FATPTNUM

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC	FATPT		FAELTM	FATPTREF
1	ABC1234	FA	ABC-1231234005	1	90567TOTNUM	NUMBER	NRT	TOBACCO CESSATION ATTEMPTS	10	10	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	2	ABC	FA	ABC-123	2	90567	OCCUR	AGE STARTED SMOKING ( Or Tobacco Product) DAILY	16	16	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
3	ABC	FA	ABC-123	3	90567	OCCUR	NUMBER	PHARMACUETIAL	TOBACCO CESSATION ATTEMPTS	N	N	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	4	4	2008-08-08
2	1234	FA	1234006	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	5	5	2008-11-12
3	1234	FA	1234007	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	3	3	2008-06-12	4	ABC	FA	ABC-123	4	90567	OCCUR	Occurrence Indicator	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING	5	ABC	FA	ABC-123	5	90567	OCCUR	Occurrence Indicator	Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING

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