The example SDTM datasets used to represent the collected data are shown below.
SUTRT represents the brand name of the tobacco product. The sponsor added the UPC code of the product to the dataset. Some sponsor may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The sponsor used the first visit date to populate SUSTPT and SUENTPT.
Row 1:
Shows that the subject used the tobacco product shown in SUTRT. 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 smokeless tobacco product shown in SUTRT. This was not the subject's usual brand of smokeless tobacco product.
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su.xpt
Row
STUDYID
DOMAIN
USUBJID
SUSEQ
SUTRT
SUCAT
SUSCAT
SUDUR
SUENDTC
SUSTRTPT
SUSTTPT
SUENRTPT
SUENTPT
1
TB901
SU
TB901005
1
XYZ Menthol King Size
SMOKED TOBACCO PRODUCT
USUAL BRAND
P20Y
BEFORE
2006-01-01
ONGOING
2006-01-01
2
TB901
SU
TB901006
2
AAA Chewing Tobacco
SMOKELESS TOBACCO PRODUCT
NOT USUAL BRAND
P3M
2006-01-01
BEFORE
2006-01-01
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Dataset Wrapper Debug Message
Please add a row column to your dataset.
The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the sponsor assigned FAOBJ to "TOBACCO". Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the sponsor to identify the product. FADTC is the date of collection, in this situation the sponsor used the visit date.