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 (DP) 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.

dp.xpt

Row	STUDYID	DOMAIN	SPTOBID	DPSEQ	DPTESTCD	DPTEST	DPCAT	DPSCAT	DPORRES	DPORRESU	DPSTRESC	DPSTRESN	DPSTRESU	DPCOLSRT
1	TOB07	DP	CIG01a	1	PACKTYP	Package Type	CIGARETTE	FILTERED, COMBUSTED	HARD PACK		HARD PACK
2	TOB07	DP	CIG01a	2	PRDQUAN	Product Quantity	CIGARETTE	FILTERED, COMBUSTED	20	CIGARETTE	20	20	CIGARETTE
3	TOB07	DP	CIG01a	3	LENGTH	Length	CIGARETTE	FILTERED, COMBUSTED	86.0	mm	86.0	86.0	mm
4	TOB07	DP	CIG01a	4	CIRCUM	Circumference	CIGARETTE	FILTERED, COMBUSTED	26.0	mm	26.0	26.0	mm
5	TOB07	DP	CIG01a	5	VENTLTN	Ventilation	CIGARETTE	FILTERED, COMBUSTED	10.0	%	10.0	10.0	%
6	TOB07	DP	CIG01a	6	CHARFLAV	Characterizing Flavor	CIGARETTE	FILTERED, COMBUSTED	MENTHOL		MENTHOL
7	TOB07	DP	CIG01a	7	HTSOURCE	Heat Source	CIGARETTE	FILTERED, COMBUSTED	xxx		xxx
8	TOB07	DP			Cigarette length	DESIGN PARAMETER SPECIFICATION		mm						TARGET
9	TOB07	DP			Cigarette length	DESIGN PARAMETER SPECIFICATION		mm						MINIMUM
10	TOB07	DP			Cigarette length	DESIGN PARAMETER SPECIFICATION		mm						MAXIMUM
11	TOB07	DP			Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION		mm						TARGET
12	TOB07	DP			Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION		mm						MINIMUM
13	TOB07	DP			Cigarette circumference or diameter ²	DESIGN PARAMETER SPECIFICATION		mm						MAXIMUM
14	TOB07	DP			Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION		mg						TARGET
15	TOB07	DP			Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION		mg						MINIMUM
16	TOB07	DP			Tobacco Filler mass	DESIGN PARAMETER SPECIFICATION		mg						MAXIMUM
17	TOB07	DP			Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION		%						TARGET
18	TOB07	DP			Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION		%						MINIMUM
19	TOB07	DP			Tobacco moisture or Oven Volatiles	DESIGN PARAMETER SPECIFICATION		%						MAXIMUM
20	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						TARGET
21	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						MINIMUM
22	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						MAXIMUM
23	TOB07	DP			Filter Ventilation			%						TARGET
24	TOB07	DP			Filter Ventilation			%						MINIMUM
25	TOB07	DP			Filter Ventilation			%						MAXIMUM
26	TOB07	DP			Tipping Paper Length			mm						TARGET
27	TOB07	DP			Tipping Paper Length			mm						MINIMUM
28	TOB07	DP			Tipping Paper Length			mm						MAXIMUM
29	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						TARGET
30	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						MINIMUM
31	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						MAXIMUM
32	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						TARGET
33	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						MINIMUM
34	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						MAXIMUM
35	TOB07	DP			Cigarette Paper band width			mm						TARGET
36	TOB07	DP			Cigarette Paper band width			mm						MINIMUM
37	TOB07	DP			Cigarette Paper band width			mm						MAXIMUM
38	TOB07	DP			Cigarette Paper band space			mm						TARGET
39	TOB07	DP			Cigarette Paper band space			mm						MINIMUM
40	TOB07	DP			Cigarette Paper band space			mm						MAXIMUM
41	TOB07	DP			Filter efficiency¹			%						TARGET
42	TOB07	DP			Filter efficiency ¹			%						MINIMUM
43	TOB07	DP			Filter efficiency¹			%						MAXIMUM
44	TOB07	DP			Denier per Filament			DPF						TARGET
45	TOB07	DP			Denier per Filament			DPF						MINIMUM
46	TOB07	DP			Denier per Filament			DPF						MAXIMUM
47	TOB07	DP			Total Denier			g/9000 m						TARGET
48	TOB07	DP			Total Denier			g/9000 m						MINIMUM
49	TOB07	DP			Total Denier			g/9000 m						MAXIMUM
50	TOB07	DP			Filter Density			g/cm³						TARGET
51	TOB07	DP			Filter Density			g/cm³						MINIMUM
52	TOB07	DP			Filter Density			g/cm³						MAXIMUM
53	TOB07	DP			Filter Length			mm						TARGET
54	TOB07	DP			Filter Length			mm						MINIMUM
55	TOB07	DP			Filter Length			mm						MAXIMUM
56	TOB07	DP			Filter Pressure Drop			mm H2O						TARGET
57	TOB07	DP			Filter Pressure Drop			mm H2O						MINIMUM
58	TOB07	DP			Filter Pressure Drop			mm H2O						MAXIMUM
59	TOB07	DP			Tobacco Rod Density			g/cm³						TARGET
60	TOB07	DP			Tobacco Rod Density			g/cm³						MINIMUM
61	TOB07	DP			Tobacco Rod Density			g/cm³						MAXIMUM
62	TOB07	DP			Cigarette Paper Length			mm						TARGET
63	TOB07	DP			Cigarette Paper Length			mm						MINIMUM
64	TOB07	DP			Cigarette Paper Length			mm						MAXIMUM

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

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tt.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTEST	TTORRESU	TTSTRESU
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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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