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.

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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Please add a row column to your dataset.

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

Dataset Debug Messages

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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	Cigarettes
TBPRSCAT	Tobacco Product Subcategory	Filtered
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
CIRCUMF	Circumference
VENTLTN	Ventilation
CHARFLAV	Characterizing Flavor

*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
LENGTH	Length
CIRCUMF	Circumference
TBFLMASS	Tobacco Filler Mass
MOISTURE	Moisture
TOCUTSIZ	Tobacco Cut Size
FLTRVENT	Filter Ventilation
TPNPLGTH	Tipping Paper Length
CIGBPPOR	Cigarette Base Paper Porosity or Permeability
BNDDIF	Cigarette Paper Band Porosity or Permeability or Band Diffusivity
CPBNDWID	Cigarette Paper Band Width
CPBNDSPC	Cigarette Paper Band Space
FLTREFF	Filter Efficiency
DPF	Denier Per Filament
TDENIER	Total Denier
FLTRDEN	Filter Density
FLTRLGTH	Filter Length
FLTPRDRP	Filter Pressure Drop
TORODDEN	Tobacco Rod Density
CIGPLGTH	Cigarette Paper Length
	Acetaldehyde
	Acrolein
	Acrylonitrile
	4-Aminobiphenyl
	1-Aminonaphthalene
	2-Aminonaphthalene
	Ammonia
	Benzene
	Benzo[a]pyrene
	1,3-Butadiene
	Carbon monoxide
	Crotonaldehyde
	Formaldehyde
	Isoprene
	Nicotine (total)
	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
	NNN - N-nitrosonornicotine
	Toluene

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Roll-Your-Own Tobacco Products	Roll-your-own tobacco is defined in section 900(15) of the FD&C Act to mean “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” The term cigarette filler is not defined in the FD&C Act. For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under
TBPRSCAT	Tobacco Product Subcategory	Roll-Your-Own Tobacco Filler
TBPRSCAT	Tobacco Product Subcategory	Roll-Your-Own Tobacco Rolling Paper
TBPRSCAT	Tobacco Product Subcategory	Filtered Cigarette Tube
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube Filter
TBPRSCAT	Tobacco Product Subcategory	Non-Filtered Cigarette Tube Paper-Tip
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
PRDQUAN	Product Quantity
CHTRFLAV	Characterizing Flavor
PACKTYP	Package Type
LENGTH	Length
WIDTH	Width
DIAMETER	Diameter
VENTLTN	Ventilation

*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
	Tobacco Cut Size
	Tobacco Moisture
	Ammonia
	Arsenic
	Cadmium
	Nicotine (total)
	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
	NNN - N-nitrosonornicotine

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reporting-harmful-and-potentially-harmful-constituents-tobacco-products-and-tobacco-smoke-under

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Cigars
TBPRSCAT	Tobacco Product Subcategory	Filtered, Sheet-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Unfiltered, Sheet-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Unfiltered, Leaf-Wrapped
TBPRSCAT	Tobacco Product Subcategory	Cigar Component
TBPRSCAT	Tobacco Product Subcategory	Cigar Tobacco Filler
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
TIP	Tip
VENTLTN	Ventilation
CHARFLAV	Characterizing Flavor
WRAPMTL	Wrapper Material

*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 Products
TBPRSCAT	Tobacco Product Subcategory	Loose Moist Snuff
TBPRSCAT	Tobacco Product Subcategory	Portioned Moist Snuff
TBPRSCAT	Tobacco Product Subcategory	Loose Snus
TBPRSCAT	Tobacco Product Subcategory	Portioned Snus
TBPRSCAT	Tobacco Product Subcategory	Loose Dry Snuff
TBPRSCAT	Tobacco Product Subcategory	Dissolvable
TBPRSCAT	Tobacco Product Subcategory	Loose Chewing Tobacco
TBPRSCAT	Tobacco Product Subcategory	Portioned Chewing Tobacco
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
CHARFLAV	Characterizing Flavor
PRTNCT	Portion count
PRTNMS	Portion mass
PRTNLGTH	Portion length
PRTNWDTH	Portion width
PRTNTHCK	Portion thickness

*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
	Acetaldehyde
	Arsenic
	Benzo[a]pyrene
	Cadmium
	Crotonaldehyde
	Formaldehyde
	Nicotine (total and free)
	NNK - 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone
	NNN - N-nitrosonornicotine
	pH
	Temperature
	Moisture Content
	?Method to stabilize or stop fermentation
	Duration of fermentation
	Type of heat treatment process
	Conditions of heat treatment process - time, temperature, moisture

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Electronic Nicotine Delivery System (ENDS) (Vapes)
TBPRSCAT	Tobacco Product Subcategory	Open E-Liquid
TBPRSCAT	Tobacco Product Subcategory	Closed E-Liquid
TBPRSCAT	Tobacco Product Subcategory	Closed E-Cigarette
TBPRSCAT	Tobacco Product Subcategory	Open E-Cigarette
TBPRSCAT	Tobacco Product Subcategory	Ends Component
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
NICTNCNC	Nicotine Concentration
PGVGRT	PG/VG Ratio*
CHTRFLAV	Characterizing Flavor
VOLUMEE	Volume, E-liquid
WATT	Wattage
BATTCAP	Battery Capacity
DISPCRTG	Disposable Cartridge
CRTVOL	Cartridge volume
HTELNUM	Number of heating elements
BATCAPC	Battery capacity
BATNOMV	Battery nominal voltage
BTCRTRT	Battery Current Rating
VENTLTN	Ventilation
ELQDVISC	E-Liquid viscosity
ELQDVOL	E-liquid volume
PNUMCNC	Particle number concentration
CTMDDIAM	Count median diameter
PM	PM 2.5

*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
DRWRST	Draw Resistance
PUFCNT	Puff count (for full tank/cartridge)
CRTVOL	Cartridge volume
HTELNUM	Number of heating elements
HTELGTH	Heating element length
HTELRST	Heating element resistance
HTELRNG	Heating element range
HTELCFG	Heating element configuration
BTVLTORG	Battery voltage operating range
BTCRTORG	Battery current operating range
BATCAPC	Battery capacity
BATNOMV	Battery nominal voltage
BTCRTRT	Battery Current Rating
BTCHTPL	Battery Charging Temperature Limits
BTDCTMPL	Battery Discharge Temperature Limits
BTENDCV	Battery end of discharge voltage
BTMXCHC	Battery maximum charging current
BTMXDCC	Battery maximum discharging current
BTULCHV	Battery upper limits charging voltage
PDUVOR	Power Delivery Unit (PDU) voltage operating range
PDUCOR	PDU current operating range
PDUWTOR	PDU wattage operating range
PDUTCTOF	PDU temperature cut-off (if applicable)
AIRFLRT	Airflow rate
PDUCRCOF	PDU current cut-off (if applicable)
INHAERT	Inhaled aerosol temperature
VENTLTN	Ventilation
ELQDVISC	E-Liquid viscosity
ELQDVOL	E-liquid volume
PNUMCNC	Particle number concentration
CTMDDIAM	Count median diameter
PM	PM 2.5

TOTESTCD	TOTEST	TOSTRESC*	Description
TBPRDCAT	Tobacco Product Category	Pipe Tobacco Products
TBPRSCAT	Tobacco Product Subcategory	Pipe
TBPRSCAT	Tobacco Product Subcategory	Pipe Tobacco Filler
TBPRSCAT	Tobacco Product Subcategory	Pipe Tobacco Component
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
CHARFLAV	Characterizing Flavor
TBCUTSTL	Tobacco Cut Style

*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	Waterpipe Tobacco Product
TBPRSCAT	Tobacco Product Subcategory	Waterpipe
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Filler
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Heat Source
TBPRSCAT	Tobacco Product Subcategory	Waterpipe Component
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
PORTLGTH	Portion Length
	Portion Width
	Portion Mass
	Portion Thickness
	Number of Hoses
	Source(s) of Energy
CHARFLAV	Characterizing Flavor

*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	Heated Tobacco Products
TBPRSCAT	Tobacco Product Subcategory	Closed Htp
TBPRSCAT	Tobacco Product Subcategory	Open Htp
TBPRSCAT	Tobacco Product Subcategory	Htp Consumable
TBPRSCAT	Tobacco Product Subcategory	Htp Component
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
PACKTYP	Package Type
PRDQUAN	Product Quantity
LENGTH	Length
DIAMETER	Diameter
WATT	Wattage
BATTCAP	Battery Capacity
CHARFLAV	Characterizing Flavor
VENTLTN	Ventilation

*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. The DPCAT variable provides the category or target of the Heated Tobacco Product the tests where the tests are administered.

DPTESTCD /TTESTCD	DPTEST/TTTEST	DPCAT	Description
MASS	Mass	Overall Product
LENGTH	Length	Overall Product
HEIGHT	Height	Overall Product
DIAMETER	Diameter	Overall Product
DRWRST	Draw Resistance	Overall Product
PUFCNT	Puff count (for full tank/cartridge)	Overall Product
PUFVOL	Puff volume	Overall Product
AIRFLRT	Airflow rate	Overall Product
VENTLTN	Ventilation	Overall Product
OPTEMP	Operational Temperature	Overall Product
TMPSENSR	Temperature sensor	Overall Product
	Material wrapper length	Overall Product
	Material wrapper width	Overall Product
	Material basis weight	Overall Product
	Material porosity	Overall Product
	Heating element source/type/approach	Heating Element	Examples: electrical, carbon, aerosol, etc.
	Heating element temperature range	Heating Element
	Heating element operational temperature	Heating Element
	Heating element maximum temperature	Heating Element
	Heating element material	Heating Element
	Heating element configuration	Heating Element
	Heating element length	Heating Element
	Heating element mass	Heating Element
	Heating element location	Heating Element

References:

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SDTM Example. Cigarette Design Parameters