SDTM Example. Cigarette Design Parameters

THIS EXAMPLE IS UNDER RECONSTRUCTION FOLLOWING DISCUSSIONS ON THE TEAM CALL 17 JAN. Updates include: 1) Simplifying PD.xpt to one record per parameter and (2), simplifying TO.xpt to a parameter-based dataset

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.

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	TOPARMCD	TOPARM	TOCAT	TOVAL	TOVALU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	Cigarette
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER	Filtered, Combusted
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	PRODUCT IDENTIFIER	Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	PRODUCT DESCRIPTOR	HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	PRODUCT DESCRIPTOR	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	PRODUCT DESCRIPTOR	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	PRODUCT DESCRIPTOR	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTN	Ventilation	PRODUCT DESCRIPTOR	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	PRODUCT DESCRIPTOR	MENTHOL

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The manufacturing parameter specifications of the tobacco product as used are represented in the Product Design Parameters (PD) domain The example below shows the target, minimum, and maximum values associated with each of 19 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU	PDCOLSRT
1	TOB07	PD	CIG01a	1	LENGTH	Length	84	83.5	84.5	mm	TARGET
2	TOB07	PD	CIG01a	4	CIRCUMF	Circumference	24.8	24.6	25	mm	TARGET
3	TOB07	PD	CIG01a	7	TBFLMASS	Tobacco Filler Mass	783	753	814	mg	TARGET
4	TOB07	PD	CIG01a	10	MOISTURE	Moisture	14	12.09	13.91	%	TARGET
5	TOB07	PD	CIG01a	13	TOCUTSIZ	Tobacco Cut Size	22	20	24	cuts/in2	TARGET
6	TOB07	PD	CIG01a	14	TOCUTSIZ	Tobacco Cut Size	27	25	29	mm	TARGET
7	TOB07	PD	CIG01a	19	FLTRVENT	Filter Ventilation	30	23	37	%	TARGET
8	TOB07	PD	CIG01a	22	TPNPLGTH	Tipping Paper Length	31	30	32	mm	TARGET
9	TOB07	PD	CIG01a	25	CIGBPPOR	Cigarette Base Paper Porosity	NA	NA	NA	CORESTA Unit (Cu)	TARGET
10	TOB07	PD	CIG01a	26	CIGBPPOR	Cigarette Base Paper Permeability	50	45	55	CORESTA Unit (Cu)	TARGET
11	TOB07	PD	CIG01a	31	BNDPOR	Cigarette Paper Band Porosity	NA	NA	NA	CORESTA Unit (Cu) or cm2/s	TARGET
12	TOB07	PD	CIG01a	32	BNDPERM	Cigarette Paper Band Permeability	10	0.2	13	CORESTA Unit (Cu) or cm2/s	TARGET
13	TOB07	PD	CIG01a	33	BNDDIF	Cigarette Paper Band Diffusivity		NA	CORESTA Unit (Cu) or cm2/s	NA	TARGET
14	TOB07	PD	CIG01a	36	BNDDIF	Cigarette Paper Band Diffusivity		NA	CORESTA Unit (Cu) or cm2/s	NA	MINIMUM
15	TOB07	PD	CIG01a	39	BNDDIF	Cigarette Paper Band Diffusivity		NA	CORESTA Unit (Cu) or cm2/s	NA	MAXIMUM
16	TOB07	PD	CIG01a	40	CPBNDWID	Cigarette Paper Band Width		7	mm	7	TARGET
17	TOB07	PD	CIG01a	41	CPBNDWID	Cigarette Paper Band Width		6.7	mm	6.7	MINIMUM
18	TOB07	PD	CIG01a	42	CPBNDWID	Cigarette Paper Band Width		7.3	mm	7.3	MAXIMUM
19	TOB07	PD	CIG01a	43	CPBNDSPC	Cigarette Paper Band Space		20	mm	20	TARGET
20	TOB07	PD	CIG01a	44	CPBNDSPC	Cigarette Paper Band Space		19.8	mm	19.8	MINIMUM
21	TOB07	PD	CIG01a	45	CPBNDSPC	Cigarette Paper Band Space		20.2	mm	20.2	MAXIMUM
22	TOB07	PD	CIG01a	46	FLTREFF	Filter Efficiency		N/A	%	N/A	TARGET
23	TOB07	PD	CIG01a	47	FLTREFF	Filter Efficiency		N/A	%	N/A	MINIMUM
24	TOB07	PD	CIG01a	48	FLTREFF	Filter Efficiency		N/A	%	N/A	MAXIMUM
25	TOB07	PD	CIG01a	49	DPF	Denier Per Filament		4		4	TARGET
26	TOB07	PD	CIG01a	50	DPF	Denier Per Filament		3.6		3.6	MINIMUM
27	TOB07	PD	CIG01a	51	DPF	Denier Per Filament		4.4		4.4	MAXIMUM
28	TOB07	PD	CIG01a	52	TDENIER	Total Denier		30000	g/9000 m	30000	TARGET
29	TOB07	PD	CIG01a	53	TDENIER	Total Denier		29100	g/9000 m	29100	MINIMUM
30	TOB07	PD	CIG01a	54	TDENIER	Total Denier		30900	g/9000 m	30900	MAXIMUM
31	TOB07	PD	CIG01a	55	FLTRDEN	Filter Density		0.1234	g/cm3	0.1234	TARGET
32	TOB07	PD	CIG01a	56	FLTRDEN	Filter Density		0.105	g/cm3	0.105	MINIMUM
33	TOB07	PD	CIG01a	57	FLTRDEN	Filter Density		0.1419	g/cm3	0.1419	MAXIMUM
34	TOB07	PD	CIG01a	58	FLTRLGTH	Filter Length		25	mm	25	TARGET
35	TOB07	PD	CIG01a	59	FLTRLGTH	Filter Length		24.5	mm	24.5	MINIMUM
36	TOB07	PD	CIG01a	60	FLTRLGTH	Filter Length		25.5	mm	25.5	MAXIMUM
37	TOB07	PD	CIG01a	61	FLTPRDRP	Filter Pressure Drop		60	mm H2O	60	TARGET
38	TOB07	PD	CIG01a	62	FLTPRDRP	Filter Pressure Drop		51	mm H2O	51	MINIMUM
39	TOB07	PD	CIG01a	63	FLTPRDRP	Filter Pressure Drop		69	mm H2O	69	MAXIMUM
40	TOB07	PD	CIG01a	64	TORODDEN	Tobacco Rod Density		0.2678	g/cm3	0.2678	TARGET
41	TOB07	PD	CIG01a	65	TORODDEN	Tobacco Rod Density		0.2437	g/cm3	0.2437	MINIMUM
42	TOB07	PD	CIG01a	66	TORODDEN	Tobacco Rod Density		0.2919	g/cm3	0.2919	MAXIMUM
43	TOB07	PD	CIG01a	67	Cigarette Paper Length	CIGPLGTH		53	mm	53	TARGET
44	TOB07	PD	CIG01a	68	Cigarette Paper Length	CIGPLGTH		52	mm	52	MINIMUM
45	TOB07	PD	CIG01a	69	Cigarette Paper Length	CIGPLGTH		54	mm	54	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