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.

Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset. This is a more traditional findings dataset structure. Advantages: it doesn't break any rules. SPTOBID is the Sponsor-defined Tobacco Product Identifier, and serves as the "subject" of all records since these are not (human) subject-level data.

Rows 1-4:	Show the records for a tobacco product identifiers that were previously represented in a separate DI dataset
Rows 5-10:	Show the product descriptors which we would have originally put in a DO-like dataset.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU	TOSTRESC	TOSTRESN	TOSTRESU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	Cigarette		Cigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Filtered, Combusted		Filtered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Cigs USA		Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Treetop Menthol King Size		Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	HARD PACK		HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	20	CIGARETTE	20	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	PRODUCT DESCRIPTOR	86.0	mm	86.0	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	PRODUCT DESCRIPTOR	26.0	mm	26.0	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTN	Ventilation	PRODUCT DESCRIPTOR	10.0	%	10.0	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	MENTHOL		MENTHOL

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The Tobacco Product Design Parameters (DP) represents the manufacturing parameter specifications of the tobacco product as used. The example below shows the target, minimum, and maximum values associated with each of 19 separate design parameters. These parameters are defined as manufacturing guidelines, not determined experimentally.

dp.xpt

Row	STUDYID	DOMAIN	SPTOBID	DPSEQ	DPTESTCD	DPTEST	DPCAT	DPORRESU	DPSTRESU	DPCOLSRT
1	TOB07	DP	CIG01a	1	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
2	TOB07	DP	CIG01a	2	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
3	TOB07	DP	CIG01a	3	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
4	TOB07	DP	CIG01a	4	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
5	TOB07	DP	CIG01a	5	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
6	TOB07	DP	CIG01a	6	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
7	TOB07	DP	CIG01a	7	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	TARGET
8	TOB07	DP	CIG01a	8	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MINIMUM
9	TOB07	DP	CIG01a	9	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MAXIMUM
10	TOB07	DP	CIG01a	10	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
11	TOB07	DP	CIG01a	11	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
12	TOB07	DP	CIG01a	12	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
13	TOB07	DP	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch ²	mm or cuts per inch ²	TARGET
14	TOB07	DP	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch ²	mm or cuts per inch ²	MINIMUM
15	TOB07	DP	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm or cuts per inch ²	mm or cuts per inch ²	MAXIMUM
16	TOB07	DP	CIG01a	16	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
17	TOB07	DP	CIG01a	17	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
18	TOB07	DP	CIG01a	18	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
19	TOB07	DP	CIG01a	19	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
20	TOB07	DP	CIG01a	20	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
21	TOB07	DP	CIG01a	21	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
22	TOB07	DP	CIG01a	22	CIGBPPOR	Cigarette Base Paper Porosity or Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	TARGET
23	TOB07	DP	CIG01a	23	CIGBPPOR	Cigarette Base Paper Porosity or Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MINIMUM
24	TOB07	DP	CIG01a	24	CIGBPPOR	Cigarette Base Paper Porosity or Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MAXIMUM
25	TOB07	DP	CIG01a	25	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	TARGET
26	TOB07	DP	CIG01a	26	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MINIMUM
27	TOB07	DP	CIG01a	27	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s	MAXIMUM
28	TOB07	DP	CIG01a	28	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
29	TOB07	DP	CIG01a	29	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
30	TOB07	DP	CIG01a	30	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
31	TOB07	DP	CIG01a	31	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
32	TOB07	DP	CIG01a	32	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
33	TOB07	DP	CIG01a	33	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
34	TOB07	DP	CIG01a	34	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
35	TOB07	DP	CIG01a	35	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
36	TOB07	DP	CIG01a	36	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
37	TOB07	DP	CIG01a	37	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	/filament	/filament	TARGET
38	TOB07	DP	CIG01a	38	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	/filament	/filament	MINIMUM
39	TOB07	DP	CIG01a	39	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	/filament	/filament	MAXIMUM
40	TOB07	DP	CIG01a	40	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	TARGET
41	TOB07	DP	CIG01a	41	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MINIMUM
42	TOB07	DP	CIG01a	42	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MAXIMUM
43	TOB07	DP	CIG01a	43	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	TARGET
44	TOB07	DP	CIG01a	44	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MINIMUM
45	TOB07	DP	CIG01a	45	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MAXIMUM
46	TOB07	DP	CIG01a	46	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
47	TOB07	DP	CIG01a	47	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
48	TOB07	DP	CIG01a	48	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
49	TOB07	DP	CIG01a	49	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	TARGET
50	TOB07	DP	CIG01a	50	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MINIMUM
51	TOB07	DP	CIG01a	51	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MAXIMUM
52	TOB07	DP	CIG01a	52	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	TARGET
53	TOB07	DP	CIG01a	53	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MINIMUM
54	TOB07	DP	CIG01a	54	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm³	g/cm³	MAXIMUM
55	TOB07	DP	CIG01a	55	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
56	TOB07	DP	CIG01a	56	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
57	TOB07	DP	CIG01a	57	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM

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The Tobacco Product Testing (TT) domain is used to represent the actual results of testing for conformance to the tobacco product design parameters shown in DP above.

tt.xpt

Row	STUDYID	DOMAIN	SPTOBID	TTSEQ	TTTESTCD	TTTEST	TTORRESU	TTSTRESU
1	TOB07	TT	CIG01a	1	LENGTH	Length	mm	mm
2	TOB07	TT	CIG01a	2	CIRCUMF	Circumference	mm	mm
3	TOB07	TT	CIG01a	3	TBFLMASS	Tobacco Filler Mass	mg	mg
4	TOB07	TT	CIG01a	4	MOISTURE	Moisture	%	%
5	TOB07	TT	CIG01a	5	TOCUTSIZ	Tobacco Cut Size	mm or cuts per inch ²	mm or cuts per inch ²
6	TOB07	TT	CIG01a	6	FLTRVENT	Filter Ventilation	%	%
7	TOB07	TT	CIG01a	7	TPNPLGTH	Tipping Paper Length	mm	mm
8	TOB07	TT	CIG01a	8	CIGBPPOR	Cigarette Base Paper Porosity or Permeability	CORESTA Unit (Cu)	CORESTA Unit (Cu)
9	TOB07	TT	CIG01a	9	BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity	CORESTA Unit (Cu) or cm²/s	CORESTA Unit (Cu) or cm²/s
10	TOB07	TT	CIG01a	10	CPBNDWID	Cigarette Paper Band Width	mm	mm
11	TOB07	TT	CIG01a	11	CPBNDSPC	Cigarette Paper Band Space	mm	mm
12	TOB07	TT	CIG01a	12	FLTREFF	Filter Efficiency	%	%
13	TOB07	TT	CIG01a	13	DPF	Denier Per Filament	/filament	/filament
14	TOB07	TT	CIG01a	14	DENIER	Denier	g/9000 m	g/9000 m
15	TOB07	TT	CIG01a	15	FLTRDEN	Filter Density	g/cm³	g/cm³
16	TOB07	TT	CIG01a	16	FLTRLGTH	Filter Length	mm	mm
17	TOB07	TT	CIG01a	17	FLTPRDRP	Filter Pressure Drop	mm H2O	mm H2O
18	TOB07	TT	CIG01a	18	TORODDEN	Tobacco Rod Density	g/cm³	g/cm³
19	TOB07	TT	CIG01a	19	CIGPLGTH	Cigarette Paper Length	mm	mm

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

The following tables illustrate the controlled terminology for the the --TESTCD and --TEST values that should be submitted for in datasets according to the examples above. for each tobacco product category. (We'll add more language as necessary to make this clearer)

Sponsors should always verify controlled terminology using the published CDISC controlled terminology for the associated codelists below

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Waterpipe Tobacco Product
TBPRSCAT	Tobacco Product Subcategory	x;y;z
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name

*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology

DPTESTCD /TTESTCD	DPTEST/TTTEST	Description

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Smokeless Tobacco Product
TBPRSCAT	Tobacco Product Subcategory	x;y;z
MANUF	Manufacturer	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name
TRADENAM	Trade Name	--	TOSTRESC not subject to controlled terminology for this TEST/TESTCD. Use verbatim name

*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

Since the conformance testing of the design parameters and the design parameters themselves speak to the same concepts, they use the same terminology

DPTESTCD /TTESTCD	DPTEST/TTTEST	Description

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