SDTM Example. Cigarette Design Parameters

This images shows the filtration zone where the ventilation occurs.

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

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 the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS.
Rows 5-10:	Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR.

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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Please add a row column to your dataset.

The ~~Tobacco~~ Product Design Parameters (PD) 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.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDTESTCD	PDTEST	PDCAT	PDORRESU	PDSTRESU	PDCOLSRT
1	TOB07	PD	CIG01a	1	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
2	TOB07	PD	CIG01a	2	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
3	TOB07	PD	CIG01a	3	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
4	TOB07	PD	CIG01a	4	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
5	TOB07	PD	CIG01a	5	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
6	TOB07	PD	CIG01a	6	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
7	TOB07	PD	CIG01a	7	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	TARGET
8	TOB07	PD	CIG01a	8	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MINIMUM
9	TOB07	PD	CIG01a	9	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	mg	mg	MAXIMUM
10	TOB07	PD	CIG01a	10	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
11	TOB07	PD	CIG01a	11	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
12	TOB07	PD	CIG01a	12	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
13	TOB07	PD	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	TARGET
14	TOB07	PD	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
15	TOB07	PD	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	MINIMUM
16	TOB07	PD	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
17	TOB07	PD	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	cuts per inch2	cuts per inch2	MAXIMUM
18	TOB07	PD	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
19	TOB07	PD	CIG01a	16	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
20	TOB07	PD	CIG01a	17	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
21	TOB07	PD	CIG01a	18	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
22	TOB07	PD	CIG01a	19	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
23	TOB07	PD	CIG01a	20	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
24	TOB07	PD	CIG01a	21	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
25	TOB07	PD	CIG01a	22	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	TARGET
26	TOB07	PD	CIG01a	22	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	TARGET
27	TOB07	PD	CIG01a	23	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MINIMUM
28	TOB07	PD	CIG01a	23	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MINIMUM
29	TOB07	PD	CIG01a	24	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MAXIMUM
30	TOB07	PD	CIG01a	24	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu)	CORESTA Unit (Cu)	MAXIMUM
31	TOB07	PD	CIG01a	25	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	TARGET
32	TOB07	PD	CIG01a	25	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	TARGET
33	TOB07	PD	CIG01a	25	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	TARGET
34	TOB07	PD	CIG01a	26	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MINIMUM
35	TOB07	PD	CIG01a	26	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MINIMUM
36	TOB07	PD	CIG01a	26	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MINIMUM
37	TOB07	PD	CIG01a	27	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MAXIMUM
38	TOB07	PD	CIG01a	27	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MAXIMUM
39	TOB07	PD	CIG01a	27	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	CORESTA Unit (Cu) or cm2/s	CORESTA Unit (Cu) or cm2/s	MAXIMUM
40	TOB07	PD	CIG01a	28	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
41	TOB07	PD	CIG01a	29	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
42	TOB07	PD	CIG01a	30	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
43	TOB07	PD	CIG01a	31	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
44	TOB07	PD	CIG01a	32	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
45	TOB07	PD	CIG01a	33	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
46	TOB07	PD	CIG01a	34	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	TARGET
47	TOB07	PD	CIG01a	35	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MINIMUM
48	TOB07	PD	CIG01a	36	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	%	%	MAXIMUM
49	TOB07	PD	CIG01a	37	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	TARGET
50	TOB07	PD	CIG01a	38	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	MINIMUM
51	TOB07	PD	CIG01a	39	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION		/filament	MAXIMUM
52	TOB07	PD	CIG01a	40	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	TARGET
53	TOB07	PD	CIG01a	41	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MINIMUM
54	TOB07	PD	CIG01a	42	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	g/9000 m	g/9000 m	MAXIMUM
55	TOB07	PD	CIG01a	43	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	TARGET
56	TOB07	PD	CIG01a	44	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	MINIMUM
57	TOB07	PD	CIG01a	45	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	MAXIMUM
58	TOB07	PD	CIG01a	46	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
59	TOB07	PD	CIG01a	47	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
60	TOB07	PD	CIG01a	48	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM
61	TOB07	PD	CIG01a	49	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	TARGET
62	TOB07	PD	CIG01a	50	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MINIMUM
63	TOB07	PD	CIG01a	51	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	mm H2O	mm H2O	MAXIMUM
64	TOB07	PD	CIG01a	52	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	TARGET
65	TOB07	PD	CIG01a	53	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	MINIMUM
66	TOB07	PD	CIG01a	54	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	g/cm3	g/cm3	MAXIMUM
67	TOB07	PD	CIG01a	55	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	TARGET
68	TOB07	PD	CIG01a	56	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MINIMUM
69	TOB07	PD	CIG01a	57	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	mm	mm	MAXIMUM

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

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRESU	PTSTRESU
1	TOB07	PT	CIG01a	1	LENGTH	Length	DESIGN PARAMETER TESTING	mm	mm
2	TOB07	PT	CIG01a	2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	mm	mm
3	TOB07	PT	CIG01a	3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	mg	mg
4	TOB07	PT	CIG01a	4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	%	%
5	TOB07	PT	CIG01a	5	TOCUTSIZ1	Tobacco Cut Size 1	DESIGN PARAMETER TESTING	cuts per inch	cuts per inch
6	TOB07	PT	CIG01a	5	TOCUTSIZ2	Tobacco Cut Size 2	DESIGN PARAMETER TESTING	mm	mm
7	TOB07	PT	CIG01a	6	FLTRVENT	Filter Ventilation	DESIGN PARAMETER TESTING	%	%
8	TOB07	PT	CIG01a	7	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	mm	mm
9	TOB07	PT	CIG01a	8	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	CORESTA Unit (Cu)	CORESTA Unit (Cu)
10	TOB07	PT	CIG01a	8	CIGBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	cm2/s	cm2/s
11	TOB07	PT	CIG01a	9	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	CORESTA Unit (Cu)	CORESTA Unit (Cu)
12	TOB07	PT	CIG01a	9	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	cm^2/s	cm2/s
13	TOB07	PT	CIG01a	9	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING
14	TOB07	PT	CIG01a	10	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	mm	mm
15	TOB07	PT	CIG01a	11	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	mm	mm
16	TOB07	PT	CIG01a	12	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	%	%
17	TOB07	PT	CIG01a	13	DPF	Denier Per Filament	DESIGN PARAMETER TESTING		/filament
18	TOB07	PT	CIG01a	14	DENIER	Total Denier	DESIGN PARAMETER TESTING	g/9000m	g/9000m
19	TOB07	PT	CIG01a	15	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	g/cm3	g/cm3
20	TOB07	PT	CIG01a	16	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	mm	mm
21	TOB07	PT	CIG01a	17	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	mm H2O	mm H2O
22	TOB07	PT	CIG01a	18	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	g/cm3	g/cm3
23	TOB07	PT	CIG01a	19	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	mm	mm

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References:

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SDTM Example. Cigarette Design Parameters