SDTM Example. Cigarette Design Parameters

The following example illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example makes use of TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

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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The manufacturing parameter specifications of the cigarette 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 23 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
1	TOB07	PD	CIG01a	1	LENGTH	Length	84	83.5	84.5	mm
2	TOB07	PD	CIG01a	2	CIRCUMF	Circumference	24.8	24.6	25	mm
3	TOB07	PD	CIG01a	3	TBFLMASS	Tobacco Filler Mass	783	753	814	mg
4	TOB07	PD	CIG01a	4	MOISTURE	Moisture	14	12.09	13.91	%
5	TOB07	PD	CIG01a	5	TOCUTSIZ	Tobacco Cut Size	22	20	24	cuts/in2
6	TOB07	PD	CIG01a	6	TOCUTSIZ	Tobacco Cut Size	27	25	29	mm
7	TOB07	PD	CIG01a	7	FLTRVENT	Filter Ventilation	30	23	37	%
8	TOB07	PD	CIG01a	8	TPNPLGTH	Tipping Paper Length	31	30	32	mm
9	TOB07	PD	CIG01a	9	CIGBPPOR	Cigarette Base Paper Porosity	NA	NA	NA	CORESTA Unit (Cu)
10	TOB07	PD	CIG01a	10	CIGBPPOR	Cigarette Base Paper Permeability	50	45	55	CORESTA Unit (Cu)
11	TOB07	PD	CIG01a	11	BNDPOR	Cigarette Paper Band Porosity	NA	NA	NA	CORESTA Unit (Cu) or cm2/s
12	TOB07	PD	CIG01a	12	BNDPERM	Cigarette Paper Band Permeability	10	0.2	13	CORESTA Unit (Cu) or cm2/s
13	TOB07	PD	CIG01a	13	BNDDIF	Cigarette Paper Band Diffusivity	NA	NA	NA	CORESTA Unit (Cu) or cm2/s
14	TOB07	PD	CIG01a	14	CPBNDWID	Cigarette Paper Band Width	7	6.7	7.3	mm
15	TOB07	PD	CIG01a	15	CPBNDSPC	Cigarette Paper Band Space	20	19.8	20.2	mm
16	TOB07	PD	CIG01a	16	FLTREFF	Filter Efficiency	NA	N/A	N/A	%
17	TOB07	PD	CIG01a	17	DPF	Denier Per Filament	4	3.6	4.4	4
18	TOB07	PD	CIG01a	18	TDENIER	Total Denier	30000	29100	30900	g/9000 m
19	TOB07	PD	CIG01a	19	FLTRDEN	Filter Density	0.1234	0.105	0.1419	g/cm3
20	TOB07	PD	CIG01a	20	FLTRLGTH	Filter Length	25	24.5	25.5	mm
21	TOB07	PD	CIG01a	21	FLTPRDRP	Filter Pressure Drop	60	51	69	mm H2O
22	TOB07	PD	CIG01a	22	TORODDEN	Tobacco Rod Density	0.2678	0.2437	0.2919	g/cm3
23	TOB07	PD	CIG01a	23	Cigarette Paper Length	CIGPLGTH	53	52	54	mm

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Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB07	PT	CIG01a	1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1
2	TOB07	PT	CIG01a	2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1
3	TOB07	PT	CIG01a	3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1
4	TOB07	PT	CIG01a	4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1
5	TOB07	PT	CIG01a	5	TOCUTSIZ1	Tobacco Cut Size 1	DESIGN PARAMETER TESTING	22	cuts per inch	22	22	cuts per inch	1
6	TOB07	PT	CIG01a	6	TOCUTSIZ2	Tobacco Cut Size 2	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1
7	TOB07	PT	CIG01a	7	FLTRVENT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1
8	TOB07	PT	CIG01a	8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	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
10	TOB07	PT	CIG01a	10	CIGBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	cm2/s	50	50	cm2/s	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
12	TOB07	PT	CIG01a	12	BNDDIF	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	cm^2/s	10	10	cm2/s	1
13	TOB07	PT	CIG01a	13	BNDDIF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	N/A		N/A	N/A		1
14	TOB07	PT	CIG01a	14	CPBNDWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1
15	TOB07	PT	CIG01a	15	CPBNDSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1
16	TOB07	PT	CIG01a	16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	N/A	%	N/A	N/A	%	1
17	TOB07	PT	CIG01a	17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1	/filament	1
18	TOB07	PT	CIG01a	18	DENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1
19	TOB07	PT	CIG01a	19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1
20	TOB07	PT	CIG01a	20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1
21	TOB07	PT	CIG01a	21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1
22	TOB07	PT	CIG01a	22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1
23	TOB07	PT	CIG01a	23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1

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References:

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SDTM Example. Cigarette Design Parameters