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Dataset wrap
Namept
Dataset2
RowSTUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESU
1TOB07PTCIG01a

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LENGTHLengthDESIGN PARAMETER TESTING
mm

mm
2TOB07PTCIG01a2CIRCUMFCircumferenceDESIGN PARAMETER TESTING
mm

mm
3TOB07PTCIG01a3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING
mg

mg
4TOB07PTCIG01a4MOISTUREMoistureDESIGN PARAMETER TESTING
%

%
5TOB07PTCIG01a5TOCUTSIZ1Tobacco Cut Size 1DESIGN PARAMETER TESTING
cuts per inch

cuts per inch
6TOB07PTCIG01a5TOCUTSIZ2Tobacco Cut Size 2DESIGN PARAMETER TESTING
mm

mm
7TOB07PTCIG01a6FLTRVENTFilter VentilationDESIGN PARAMETER TESTING
%

%
8TOB07PTCIG01a7TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING
mm

mm
9TOB07PTCIG01a8CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)
10TOB07PTCIG01a8CIGBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING
cm2/s

cm2/s
11TOB07PTCIG01a9BNDDIFCigarette Paper Band PorosityDESIGN PARAMETER TESTING
CORESTA Unit (Cu)

CORESTA Unit (Cu)
12TOB07PTCIG01a9BNDDIFCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING
cm^2/s

cm2/s
13TOB07PTCIG01a9BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTING




14TOB07PTCIG01a10CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING
mm

mm
15TOB07PTCIG01a11CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING
mm

mm
16TOB07PTCIG01a12FLTREFFFilter EfficiencyDESIGN PARAMETER TESTING
%

%
17TOB07PTCIG01a13DPFDenier Per FilamentDESIGN PARAMETER TESTING



/filament
18TOB07PTCIG01a14DENIERTotal DenierDESIGN PARAMETER TESTING
g/9000m

g/9000m
19TOB07PTCIG01a15FLTRDENFilter DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3
20TOB07PTCIG01a16FLTRLGTHFilter LengthDESIGN PARAMETER TESTING
mm

mm
21TOB07PTCIG01a17FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING
mm H2O

mm H2O
22TOB07PTCIG01a18TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING
g/cm3

g/cm3
23TOB07PTCIG01a19CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING
mm

mm

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)

Info

Sponsors should always verify controlled terminology using the published CDISC controlled terminology for the associated codelists below

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titleCigarettes

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titleCigarettes Product Identifiers and Descriptors

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleCigarettes Product Design Parameters and Conformance Testing

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titleRoll-Your-Own Tobacco Products

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titleRoll-Your-Own Tobacco Product Identifiers and Descriptors

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleRoll-Your-Own Tobacco Product Design Parameters and Conformance Testing

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Tube Mass

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

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titleCigars

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titleCigars Product Identifiers and Descriptors

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Filtered, Sheet-Wrapped

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.


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titleCigars Product Design Parameters and Conformance Testing

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Tobacco filler mass 

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Cigar, Filtered Sheet Wrapped

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Cigar length 

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Cigar Length 

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titleSmokeless Tobacco Products

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titleSmokeless Tobacco Product Identifiers and Descriptors

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Loose Moist Snuff

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Portion count 

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleSmokeless Tobacco Product Design Parameters and Conformance Testing

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Pouch material thickness

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Pouch material porosity or permeability

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Pouch material basis weight

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Nicotine dissolution rate

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titleElectronic Nicotine Delivery Systems (ENDS) (Vapes)

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titleENDS (Vapes) Product Identifiers and Descriptors

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Open E-Liquid

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PACKTYP

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleENDS (Vapes) Product Design Parameters and Conformance Testing

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DRWRST

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titlePipe Tobacco Products

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titlePipe Tobacco Product Identifiers and Descriptors

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Pipe

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titlePipe Tobacco Products Design Parameters and Conformance Testing

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Bowl chamber outer diameter 

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titleWaterpipe Tobacco Products

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titleWaterpipe Tobacco Product Identifiers and Descriptors

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Waterpipe

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleWaterpipe Tobacco Product Design Parameters and Conformance Testing

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Hose length 

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Heating element mass 

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titleHeated Tobacco Products

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titleHeated Tobacco Product Identifiers and Descriptors

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Closed Htp

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*Where TOSTRESC is subject to controlled terminology, use the value (or one of the values) shown in this column.

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titleHeated Tobacco Products Design Parameters and Conformance Testing

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Tobacco mass 

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References:

  1. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/

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