SDTM Example. Cigarette Design Parameters

This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Device Identifiers (DI) is a study reference dataset that provides a mechanism for uniquely identifying a device (tobacco product). The primary purpose of this dataset is to provide a list of the devices (products) used in an application or study and to provide identifying information for each device (product) --note: will update as domains change or change the explanatory text--, such as device (product category) type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Device Identifier (SPDEVID), a consistent variable, that is available for use in other domains where data pertaining to the device (product) may be found.

Rows 1-5:	Show the records for a device given SPDEVID of CIG01a.
Rows 3-5:	Show the tobacco product is a filtered, combusted type of cigarette.

di.xpt

Row	STUDYID	DOMAIN	SPDEVID	DISEQ	DIPARMCD	DIPARM	DIVAL
1	TOB07	DI	CIG01a	1	DEVTYPE	Device Type	Tobacco Product
2	TOB07	DI	CIG01a	2	TBPRDCAT	Tobacco Product Category	Cigarette
3	TOB07	DI	CIG01a	3	TBPRSCAT	Tobacco Product Subcategory	Filtered, Combusted
4	TOB07	DI	CIG01a	4	MANUF	Manufacturer	Joes Cigs USA
5	TOB07	DI	CIG01a	5	TRADENAM	Trade Name	Treetop Methol King Size

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The Device-In-Use (DU) domain represents properties of the device (tobacco product) as used. The DU domain now contains information that was previously found in the Device Properties (DO) domain). The domain now captures characteristics and properties of a device that do not change and can include characteristics and properties that can vary from subject to subject (not applicable here but added for reviewers comprehension). This is a findings domain and defines important characteristics of a device (product) that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the device (product). Each property is identified using controlled terminology and is stored in DUTESTCD/DUTEST.

Rows 1-4:	Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference.
Row 5:	Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1
Row 6:	Shows the characterizing flavor is menthol for this package of cigarettes.
Row 7:	Shows the heat source is xxx.

du.xpt

Row	STUDYID	DOMAIN	SPDEVID	DUSEQ	DUTESTCD	DUTEST	DUCAT	DUSCAT	DUORRES	DUORRESU	DUSTRESC	DUSTRESN	DUSTRESU
1	TOB07	DU	CIG01a	1	PACKTYP	Package Type	CIGARETTE	FILTERED, COMBUSTED	HARD PACK		HARD PACK
2	TOB07	DU	CIG01a	2	PRDQUAN	Product Quantity	CIGARETTE	FILTERED, COMBUSTED	20	CIGARETTE	20	20	CIGARETTE
3	TOB07	DU	CIG01a	3	LENGTH	Length	CIGARETTE	FILTERED, COMBUSTED	86.0	mm	86.0	86.0	mm
4	TOB07	DU	CIG01a	4	CIRCUM	Circumference	CIGARETTE	FILTERED, COMBUSTED	26.0	mm	26.0	26.0	mm
5	TOB07	DU	CIG01a	5	VENTLTN	Ventilation	CIGARETTE	FILTERED, COMBUSTED	10.0	%	10.0	10.0	%
6	TOB07	DU	CIG01a	6	CHARFLAV	Characterizing Flavor	CIGARETTE	FILTERED, COMBUSTED	MENTHOL		MENTHOL
7	TOB07	DU	CIG01a	7	HTSOURCE	Heat Source	CIGARETTE	FILTERED, COMBUSTED	xxx		xxx

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

This images shows the filtration zone where the ventilation occurs.

Question - is this helpful? Will need permission. This is from the second reference.

References:

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SDTM Example. Cigarette Design Parameters