SDTM Example. Cigarette Design Parameters

Tobacco domains

DI = TO for Tobacco Product Identifier

SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier

DO/DU = Tobacco Design Parameters (DP)

LB = Tobacco Product Testing (TT)

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
1	TOB07	TO	CIG01a	1
2	TOB07	TO	CIG01a	2
3	TOB07	TO	CIG01a	3
4	TOB07	TO	CIG01a	4

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

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	TBPRDCAT	Tobacco Product Category			Cigarette		Cigarette
2	TOB07	DP	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory			Filtered, Combusted		Filtered, Combusted
3	TOB07	DP	CIG01a	3	MANUF	Manufacturer			Joes Cigs USA		Joes Cigs USA
4	TOB07	DP	CIG01a	4	TRADENAM	Trade Name			Treetop Methol King Size		Treetop Methol King Size
5	TOB07	DP	CIG01a	5	PACKTYP	Package Type			HARD PACK		HARD PACK
6	TOB07	DP	CIG01a	6	PRDQUAN	Product Quantity			20	CIGARETTE	20	20	CIGARETTE
7	TOB07	DP	CIG01a	7	LENGTH	Length			86.0	mm	86.0	86.0	mm
8	TOB07	DP	CIG01a		CIRCUMF	Circumference			26.0	mm	26.0	26.0	mm
9	TOB07	DP	CIG01a	5	VENTLTN	Ventilation			10.0	%	10.0	10.0	%
10	TOB07	DP	CIG01a	6	CHARFLAV	Characterizing Flavor			MENTHOL		MENTHOL
11	TOB07	DP	CIG01a	7	HTSOURCE	Heat Source			xxx		xxx
12	TOB07	DP			LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm						TARGET
13	TOB07	DP			LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm						MINIMUM
14	TOB07	DP			LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm						MAXIMUM
15	TOB07	DP			Cigarette circumference or diameter ²		DESIGN PARAMETER SPECIFICATION	mm						TARGET
16	TOB07	DP			Cigarette circumference or diameter ²		DESIGN PARAMETER SPECIFICATION	mm						MINIMUM
17	TOB07	DP			Cigarette circumference or diameter ²		DESIGN PARAMETER SPECIFICATION	mm						MAXIMUM
18	TOB07	DP			Tobacco Filler mass		DESIGN PARAMETER SPECIFICATION	mg						TARGET
19	TOB07	DP			Tobacco Filler mass		DESIGN PARAMETER SPECIFICATION	mg						MINIMUM
20	TOB07	DP			Tobacco Filler mass		DESIGN PARAMETER SPECIFICATION	mg						MAXIMUM
21	TOB07	DP			Tobacco moisture or Oven Volatiles		DESIGN PARAMETER SPECIFICATION	%						TARGET
22	TOB07	DP			Tobacco moisture or Oven Volatiles		DESIGN PARAMETER SPECIFICATION	%						MINIMUM
23	TOB07	DP			Tobacco moisture or Oven Volatiles		DESIGN PARAMETER SPECIFICATION	%						MAXIMUM
24	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						TARGET
25	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						MINIMUM
26	TOB07	DP			Tobacco cut size			mm or cuts per inch ²						MAXIMUM
27	TOB07	DP			Filter Ventilation			%						TARGET
28	TOB07	DP			Filter Ventilation			%						MINIMUM
29	TOB07	DP			Filter Ventilation			%						MAXIMUM
30	TOB07	DP			Tipping Paper Length			mm						TARGET
31	TOB07	DP			Tipping Paper Length			mm						MINIMUM
32	TOB07	DP			Tipping Paper Length			mm						MAXIMUM
33	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						TARGET
34	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						MINIMUM
35	TOB07	DP			Cigarette base paper Porosity or Permeability			CORESTA Unit (Cu)						MAXIMUM
36	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						TARGET
37	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						MINIMUM
38	TOB07	DP			Cigarette Paper band porosity or permeability or band diffusivity			CORESTA Unit (Cu) or cm²/s						MAXIMUM
39	TOB07	DP			Cigarette Paper band width			mm						TARGET
40	TOB07	DP			Cigarette Paper band width			mm						MINIMUM
41	TOB07	DP			Cigarette Paper band width			mm						MAXIMUM
42	TOB07	DP			Cigarette Paper band space			mm						TARGET
43	TOB07	DP			Cigarette Paper band space			mm						MINIMUM
44	TOB07	DP			Cigarette Paper band space			mm						MAXIMUM
45	TOB07	DP			Filter efficiency¹			%						TARGET
46	TOB07	DP			Filter efficiency ¹			%						MINIMUM
47	TOB07	DP			Filter efficiency¹			%						MAXIMUM
48	TOB07	DP			Denier per Filament			DPF						TARGET
49	TOB07	DP			Denier per Filament			DPF						MINIMUM
50	TOB07	DP			Denier per Filament			DPF						MAXIMUM
51	TOB07	DP			Total Denier			g/9000 m						TARGET
52	TOB07	DP			Total Denier			g/9000 m						MINIMUM
53	TOB07	DP			Total Denier			g/9000 m						MAXIMUM
54	TOB07	DP			Filter Density			g/cm³						TARGET
55	TOB07	DP			Filter Density			g/cm³						MINIMUM
56	TOB07	DP			Filter Density			g/cm³						MAXIMUM
57	TOB07	DP			Filter Length			mm						TARGET
58	TOB07	DP			Filter Length			mm						MINIMUM
59	TOB07	DP			Filter Length			mm						MAXIMUM
60	TOB07	DP			Filter Pressure Drop			mm H2O						TARGET
61	TOB07	DP			Filter Pressure Drop			mm H2O						MINIMUM
62	TOB07	DP			Filter Pressure Drop			mm H2O						MAXIMUM
63	TOB07	DP			Tobacco Rod Density			g/cm³						TARGET
64	TOB07	DP			Tobacco Rod Density			g/cm³						MINIMUM
65	TOB07	DP			Tobacco Rod Density			g/cm³						MAXIMUM
66	TOB07	DP			Cigarette Paper Length			mm						TARGET
67	TOB07	DP			Cigarette Paper Length			mm						MINIMUM
68	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

Dataset Debug Message

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Dataset Wrapper Debug Message

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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