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	PDORRES	PDORRESU	PDSTRESC	PDSTRESN	PDSTRESU	PDCOLSRT
1	TOB07	PD	CIG01a	1	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	84	mm	84	84	mm	TARGET
2	TOB07	PD	CIG01a	2	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	83.5	mm	83.5	83.5	mm	MINIMUM
3	TOB07	PD	CIG01a	3	LENGTH	Length	DESIGN PARAMETER SPECIFICATION	84.5	mm	84.5	84.5	mm	MAXIMUM
4	TOB07	PD	CIG01a	4	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	24.8	mm	24.8	24.8	mm	TARGET
5	TOB07	PD	CIG01a	5	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	24.3	mm	24.3	24.3	mm	MINIMUM
6	TOB07	PD	CIG01a	6	CIRCUMF	Circumference	DESIGN PARAMETER SPECIFICATION	25.3	mm	25.3	25.3	mm	MAXIMUM
7	TOB07	PD	CIG01a	7	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	783	mg	783	783	mg	TARGET
8	TOB07	PD	CIG01a	8	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	753	mg	753	753	mg	MINIMUM
9	TOB07	PD	CIG01a	9	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER SPECIFICATION	813	mg	813	813	mg	MAXIMUM
10	TOB07	PD	CIG01a	10	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	13	%	13	13	%	TARGET
11	TOB07	PD	CIG01a	11	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	12.09	%	12.09	12.09	%	MINIMUM
12	TOB07	PD	CIG01a	12	MOISTURE	Moisture	DESIGN PARAMETER SPECIFICATION	13.91	%	13.91	13.91	%	MAXIMUM
13	TOB07	PD	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	22	cuts per inch	22	22	cuts per inch2	TARGET
14	TOB07	PD	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	27	mm	27	27	mm	TARGET
15	TOB07	PD	CIG01a	15	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	20	cuts per inch	20	20	cuts per inch2	MINIMUM
16	TOB07	PD	CIG01a	16	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	25	mm	25	25	mm	MINIMUM
17	TOB07	PD	CIG01a	17	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	24	cuts per inch	24	24	cuts per inch2	MAXIMUM
18	TOB07	PD	CIG01a	18	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER SPECIFICATION	29	mm	29	29	mm	MAXIMUM
19	TOB07	PD	CIG01a	19	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	30	%	30	30	%	TARGET
20	TOB07	PD	CIG01a	20	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	23	%	23	23	%	MINIMUM
21	TOB07	PD	CIG01a	21	FLTRVENT	Filter Ventilation	DESIGN PARAMETER SPECIFICATION	37	%	37	37	%	MAXIMUM
22	TOB07	PD	CIG01a	22	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	31	mm	31	31	mm	TARGET
23	TOB07	PD	CIG01a	23	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	30	mm	30	30	mm	MINIMUM
24	TOB07	PD	CIG01a	24	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER SPECIFICATION	32	mm	32	32	mm	MAXIMUM
25	TOB07	PD	CIG01a	25	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu)	NA	NA	CORESTA Unit (Cu)	TARGET
26	TOB07	PD	CIG01a	26	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	50	CORESTA Unit (Cu)	50	50	CORESTA Unit (Cu)	TARGET
27	TOB07	PD	CIG01a	27	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu)	NA	NA	CORESTA Unit (Cu)	MINIMUM
28	TOB07	PD	CIG01a	28	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	45	CORESTA Unit (Cu)	45	45	CORESTA Unit (Cu)	MINIMUM
29	TOB07	PD	CIG01a	29	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu)	NA	NA	CORESTA Unit (Cu)	MAXIMUM
30	TOB07	PD	CIG01a	30	CIGBPPOR	Cigarette Base Paper Permeability	DESIGN PARAMETER SPECIFICATION	55	CORESTA Unit (Cu)	55	55	CORESTA Unit (Cu)	MAXIMUM
31	TOB07	PD	CIG01a	31	BNDPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	TARGET
32	TOB07	PD	CIG01a	32	BNDPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	10	CORESTA Unit (Cu) or cm2/s	10	10	CORESTA Unit (Cu) or cm2/s	TARGET
33	TOB07	PD	CIG01a	33	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	TARGET
34	TOB07	PD	CIG01a	34	BNDPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	MINIMUM
35	TOB07	PD	CIG01a	35	BNDPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	0.2	CORESTA Unit (Cu) or cm2/s	0.2	0.2	CORESTA Unit (Cu) or cm2/s	MINIMUM
36	TOB07	PD	CIG01a	36	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	MINIMUM
37	TOB07	PD	CIG01a	37	BNDPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	MAXIMUM
38	TOB07	PD	CIG01a	38	BNDPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER SPECIFICATION	13	CORESTA Unit (Cu) or cm2/s	13	13	CORESTA Unit (Cu) or cm2/s	MAXIMUM
39	TOB07	PD	CIG01a	39	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER SPECIFICATION	NA	CORESTA Unit (Cu) or cm2/s	NA	NA	CORESTA Unit (Cu) or cm2/s	MAXIMUM
40	TOB07	PD	CIG01a	40	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	7	mm	7	7	mm	TARGET
41	TOB07	PD	CIG01a	41	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	6.7	mm	6.7	6.7	mm	MINIMUM
42	TOB07	PD	CIG01a	42	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER SPECIFICATION	7.3	mm	7.3	7.3	mm	MAXIMUM
43	TOB07	PD	CIG01a	43	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	20	mm	20	20	mm	TARGET
44	TOB07	PD	CIG01a	44	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	19.8	mm	19.8	19.8	mm	MINIMUM
45	TOB07	PD	CIG01a	45	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER SPECIFICATION	20.2	mm	20.2	20.2	mm	MAXIMUM
46	TOB07	PD	CIG01a	46	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	N/A	%	N/A	N/A	%	TARGET
47	TOB07	PD	CIG01a	47	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	N/A	%	N/A	N/A	%	MINIMUM
48	TOB07	PD	CIG01a	48	FLTREFF	Filter Efficiency	DESIGN PARAMETER SPECIFICATION	N/A	%	N/A	N/A	%	MAXIMUM
49	TOB07	PD	CIG01a	49	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	4		4	4	/filament	TARGET
50	TOB07	PD	CIG01a	50	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	3.6		3.6	3.6	/filament	MINIMUM
51	TOB07	PD	CIG01a	51	DPF	Denier Per Filament	DESIGN PARAMETER SPECIFICATION	4.4		4.4	4.4	/filament	MAXIMUM
52	TOB07	PD	CIG01a	52	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	30000	g/9000 m	30000	30000	g/9000 m	TARGET
53	TOB07	PD	CIG01a	53	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	29100	g/9000 m	29100	29100	g/9000 m	MINIMUM
54	TOB07	PD	CIG01a	54	TDENIER	Total Denier	DESIGN PARAMETER SPECIFICATION	30900	g/9000 m	30900	30900	g/9000 m	MAXIMUM
55	TOB07	PD	CIG01a	55	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	0.1234	g/cm3	0.1234	0.1234	g/cm3	TARGET
56	TOB07	PD	CIG01a	56	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	0.105	g/cm3	0.105	0.105	g/cm3	MINIMUM
57	TOB07	PD	CIG01a	57	FLTRDEN	Filter Density	DESIGN PARAMETER SPECIFICATION	0.1419	g/cm3	0.1419	0.1419	g/cm3	MAXIMUM
58	TOB07	PD	CIG01a	58	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	25	mm	25	25	mm	TARGET
59	TOB07	PD	CIG01a	59	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	24.5	mm	24.5	24.5	mm	MINIMUM
60	TOB07	PD	CIG01a	60	FLTRLGTH	Filter Length	DESIGN PARAMETER SPECIFICATION	25.5	mm	25.5	25.5	mm	MAXIMUM
61	TOB07	PD	CIG01a	61	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	60	mm H2O	60	60	mm H2O	TARGET
62	TOB07	PD	CIG01a	62	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	51	mm H2O	51	51	mm H2O	MINIMUM
63	TOB07	PD	CIG01a	63	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER SPECIFICATION	69	mm H2O	69	69	mm H2O	MAXIMUM
64	TOB07	PD	CIG01a	64	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	0.2678	g/cm3	0.2678	0.2678	g/cm3	TARGET
65	TOB07	PD	CIG01a	65	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	0.2437	g/cm3	0.2437	0.2437	g/cm3	MINIMUM
66	TOB07	PD	CIG01a	66	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER SPECIFICATION	0.2919	g/cm3	0.2919	0.2919	g/cm3	MAXIMUM
67	TOB07	PD	CIG01a	67	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	53	mm	53	53	mm	TARGET
68	TOB07	PD	CIG01a	68	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	52	mm	52	52	mm	MINIMUM
69	TOB07	PD	CIG01a	69	Cigarette Paper Length	CIGPLGTH	DESIGN PARAMETER SPECIFICATION	54	mm	54	54	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	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM	PTTPT	PTTPTNUM
1	TOB07	PT	CIG01a	1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1	Week 0	1
2	TOB07	PT	CIG01a	2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1	Week 0	1
3	TOB07	PT	CIG01a	3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1	Week 0	1
4	TOB07	PT	CIG01a	4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1	Week 0	1
5	TOB07	PT	CIG01a	5	TOCUTSIZ1	Tobacco Cut Size 1	DESIGN PARAMETER TESTING	22	cuts per inch	22	22	cuts per inch	1	Week 0	1
6	TOB07	PT	CIG01a	6	TOCUTSIZ2	Tobacco Cut Size 2	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1	Week 0	1
7	TOB07	PT	CIG01a	7	FLTRVENT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1	Week 0	1
8	TOB07	PT	CIG01a	8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	1	Week 0	1
9	TOB07	PT	CIG01a	9	CIGBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	N/A	CORESTA Unit (Cu)	N/A	N/A	CORESTA Unit (Cu)	1	Week 0	1
10	TOB07	PT	CIG01a	10	CIGBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	cm2/s	50	50	cm2/s	1	Week 0	1
11	TOB07	PT	CIG01a	11	BNDDIF	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	N/A	CORESTA Unit (Cu)	N/A	N/A	CORESTA Unit (Cu)	1	Week 0	1
12	TOB07	PT	CIG01a	12	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	cm^2/s	10	10	cm2/s	1	Week 0	1
13	TOB07	PT	CIG01a	13	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	N/A		N/A	N/A		1	Week 0	1
14	TOB07	PT	CIG01a	14	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1	Week 0	1
15	TOB07	PT	CIG01a	15	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1	Week 0	1
16	TOB07	PT	CIG01a	16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	N/A	%	N/A	N/A	%	1	Week 0	1
17	TOB07	PT	CIG01a	17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1	/filament	1	Week 0	1
18	TOB07	PT	CIG01a	18	DENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1	Week 0	1
19	TOB07	PT	CIG01a	19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1	Week 0	1
20	TOB07	PT	CIG01a	20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1	Week 0	1
21	TOB07	PT	CIG01a	21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1	Week 0	1
22	TOB07	PT	CIG01a	22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1	Week 0	1
23	TOB07	PT	CIG01a	23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1	Week 0	1

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References:

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SDTM Example. Cigarette Design Parameters