This example illustrates how typical tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapies for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco strips. Usage of these products are represented in the SU domain.
Tobacco Usage History
Record the type of tobacco product used
What is the type of tobacco product used by the subject?
SUSCAT
Record the brand name of the tobacco product used.
What was the name of the tobacco product?
SUTRT
Indicate if this is the subject usual brand of tobacco product used
Is this the subject usual brand of tobacco product?
SUSCAT
<USUAL, BRAND, NOT, USUAL, or BRAND codelist>
Provide the duration of the tobacco product used
FAORRES
_________________
Select the appropriate duration unit of the tobacco product used
Unit
SUCDURUFAORRESU
Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection and the end date should be left blank.
Is the tobacco use ongoing?
SUONGOSUENRF or SUENRTPT
<NY codelist>
Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank.
SUENDATSUENDTC
_ _ / _ _ _ / _ _ _ _
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
SUSCAT
1
What is the type of tobacco product used by the subject?
Record the brand name of the tobacco product used.
Text
SUTRT
BRAND X;BRAND; BRAND Z;
SUSCAT
5
Is this the subject usual brand of tobacco product?
Substance Use Subcategory
Indicate if this is the subject usual brand of tobacco product used
Text
SUSCAT
USUAL BRAND;
NOT USUAL BRAND
Yes; No
FAORRES
5
What was the duration of use of the tobacco product ?
Duration
Provide the duration of the tobacco product used
Text
FAORRES
Prompt
SUCDURU
6
What was the unit of duration of use of the tobacco product?
Unit
Select the appropriate duration unit of the tobacco product used
Text
FAORRESU
DAYS; MONTHS; YEARS;
Prompt
SUONGO
9
Is the tobacco use ongoing?
Ongoing
Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection and the end date should be left blank.
Text
SUENRF; SUENRTPT
SUENRF or SUENRTPT
(NY)
Yes
checkbox
SUENDAT
10
What was the end date?
End Date
Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank.
Date
SUENDTC
prompt
Row 1:
Shows that the subject used this tobacco product. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing,
Row 2:
Shows that the subject used this smokeless tobacco product. This was not the subject usual brand of smokeless tobacco product.
$titleHtml
su.xpt
Row
STUDYID
DOMAIN
USUBJID
SPTOBID
SUSEQ
SUTRT
SUCAT
SUSCAT
SUOCCUR
SUSTAT
SUREASND
SUDOSE
SUDOSU
SUDOSFRQ
SUSTDTC
SUENDTC
SUSTTPT
SUSTRTPT
SUENTPT
SUENRTPT
1
TB901
SU
TB901005
BAND XYZ
1
BRAND XYZ CIGARTTES
SMOKED TOBACCO PRODUCT
USUAL BRAND
Y
2
PACK
QD
2006-01-01
BEFORE
2006-01-01
ONGOING
2
TB901
SU
TB901006
BRAND ZZZ
1
SNUS TOBACCO BRAND ZZZ
SMOKELESS TOBACCO PRODUCT
NOT USUAL BRAND
Y
2002
2006-01-01
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
In this situation, the sponsor maintained an in-house dictionary of tobacco brands. This allowed this sponsor to study products across studies using the same tobacco product code for each brand of tobacco product. These codes were used to create a TO domain. This domain provided details on the brand of tobacco product used by the subject. Data for two brands of tobacco are shown.
to.xpt
to.xpt
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOTESTCD
TOTEST
TOCAT
TOORRES
TOORRESU
TOSTRESC
TOSTRESN
TOSTRESU
1
TB901
TO
BRAND XYZ
1
TBPRDCAT
Tobacco Product Category
PRODUCT IDENTIFIER
Cigarette
Cigarette
2
TB901
TO
BRAND XYZ
2
TBPRSCAT
Tobacco Product Subcategory
PRODUCT IDENTIFIER
Filtered, Combusted
Filtered, Combusted
3
TB901
TO
BRAND XYZ
3
MANUF
Manufacturer
PRODUCT IDENTIFIER
Brand XYZ Company
Brand XYZ Company
4
TB901
TO
BRAND XYZ
4
TRADENAM
Trade Name
PRODUCT IDENTIFIER
XYZ Menthol King Size
XYZ Menthol King Size
1
TB901
TO
BRAND ZZZ
1
TBPRDCAT
Tobacco Product Category
PRODUCT IDENTIFIER
Smokeless Tobacco Product
Smokeless Tobacco Product
2
TB901
TO
BRAND ZZZ
2
TBPRSCAT
Tobacco Product Subcategory
PRODUCT IDENTIFIER
Snus, portioned
Snus, portioned
3
TB901
TO
BRAND ZZZ
3
MANUF
Manufacturer
PRODUCT IDENTIFIER
ZZZ Smokeless
ZZZ Smokeless
Dataset Debug Message
There is a leading, trailing, or non-breaking space in the dataset.