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.

Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???

Rows 1-4:	Show the records for a tobacco product given SPTOBID of CIG01a.
Rows 3-4:	Show the tobacco product is a filtered, combusted type of cigarette.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOVAL
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	Cigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	Filtered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	Treetop Methol King Size

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The Tobacco Product Design Parameters (TP) is (similar to the Device Properties (DO) domain) represents properties of the tobacco product as used. This is a findings domain and defines important characteristics of a 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 product. Each property is identified using controlled terminology and is stored in TTTESTCD/TTTEST.

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.

tt.xpt

tp.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTESTCD	TTTEST	TTCAT	TTSCAT	TTORRES	TTORRESU	TTSTRESC	TTSTRESN	TTSTRESU
1	TOB07	TT	CIG01a	1	PACKTYP	Package Type	CIGARETTE	FILTERED, COMBUSTED	HARD PACK		HARD PACK
2	TOB07	TT	CIG01a	2	PRDQUAN	Product Quantity	CIGARETTE	FILTERED, COMBUSTED	20	CIGARETTE	20	20	CIGARETTE
3	TOB07	TT	CIG01a	3	LENGTH	Length	CIGARETTE	FILTERED, COMBUSTED	86.0	mm	86.0	86.0	mm
4	TOB07	TT	CIG01a	4	CIRCUM	Circumference	CIGARETTE	FILTERED, COMBUSTED	26.0	mm	26.0	26.0	mm
5	TOB07	TT	CIG01a	5	VENTLTN	Ventilation	CIGARETTE	FILTERED, COMBUSTED	10.0	%	10.0	10.0	%
6	TOB07	TT	CIG01a	6	CHARFLAV	Characterizing Flavor	CIGARETTE	FILTERED, COMBUSTED	MENTHOL		MENTHOL
7	TOB07	TT	CIG01a	7	HTSOURCE	Heat Source	CIGARETTE	FILTERED, COMBUSTED	xxx		xxx

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Rows 1-4:
Row 5:	S
Row 6:
Row 7:

Row Captions Debug Message

Please provide a caption for every row caption label.

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tt.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTEST	TTORRESU	TTSTRESU
1	TOB07	TT	CIG01a	1	Tobacco Filler mass	mg	mg
1	TOB07	TT	CIG01a	1	Tobacco Filler mass	mg	mg
1	TOB07	TT	CIG01a	1	Tobacco Filler mass	mg	mg


2	TOB07	TT	CIG01a	2	Tobacco moisture or Oven Volatiles	%	%
3	TOB07	TT	CIG01a	3	Tobacco cut size	mm or cuts per inch ²	mm or cuts per inch ²
4	TOB07	TT	CIG01a	4	Tobacco Rod density	g/cm³	g/cm³
5	TOB07	TT	CIG01a	5	Filter Ventilation	%	%
6	TOB07	TT	CIG01a	6	Cigarette base paper Porosity or Permeability	CORESTA Unit (Cu)	CORESTA Unit (Cu)
7	TOB07	TT	CIG01a	7	Cigarette Paper band porosity or permeability or band diffusivity	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s
8	TOB07	TT	CIG01a	8	Filter efficiency¹	%	%
9	TOB07	TT	CIG01a	9	Denier per Filament	DPF	DPF
10	TOB07	TT	CIG01a	10	Total Denier	g/9000 m	g/9000 m
11	TOB07	TT	CIG01a	11	Filter Density	g/cm³	g/cm³
12	TOB07	TT	CIG01a	12	Filter Pressure Drop	mm H2O	mm H2O

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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