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Option 1 to address Steve H's suggestion of combining our previous product identifiers and product descriptors into a single dataset. This dataset structure deviates from the norm by adding a units variable (TOVALU). This one may be a tough sell to the CDISC standards development community
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All rows: | 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. We have added TOVALU to allow for units |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOVAL | TOVALU |
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1 | TOB07 | TO | CIG01a | 1 | TBPRDCAT | Tobacco Product Category | Cigarette |
| 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | Filtered, Combusted |
| 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | Joes Cigs USA |
| 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | Treetop Menthol King Size |
| 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | HARD PACK |
| 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity | 20 | CIGARETTE | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length | 86.0 | mm | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference | 26.0 | mm | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation | 10.0 | % | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | MENTHOL |
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Option 2 to address 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. Rowcaps |
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All rows: | 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. |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT |
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TOSCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU | TOCOLSRT |
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1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Cigarette |
| Cigarette |
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| 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Filtered, Combusted |
| Filtered, Combusted |
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| 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Cigs USA |
| Joes Cigs USA |
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| 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Treetop Menthol King Size |
| Treetop Menthol King Size |
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| 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | HARD PACK |
| HARD PACK |
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| 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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The Tobacco Product Design Parameters (DP) is (similar to the Device Properties (DO) domain) represents properties represents the manufacturing parameters of the tobacco product as used. This is a findings domain and defines important characteristics of a product that the sponsor manufacturer (tobacco researcher) wishes to include in the submission but do not form part of the unique sponsor-defined identification of the product. Each property is identified using controlled terminology and is stored in TTTESTCD/TTTEST.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.
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Rows 1-4: | Show the package type is a hard pack that each contain 20 cigarettes that are 86.0 mm long and 26.0 mm in circumference. |
Row 5: | Shows the ventilation flow expressed as a percentage. Ventilation is the aspiration of atmospheric air in an unlit cigarette. (ISO 9512:2019) - 1 |
Row 6: | Shows the characterizing flavor is menthol for this package of cigarettes. |
Row 7: | Shows the heat source is xxx. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | DPSEQ | DPTESTCD | DPTEST | DPCAT | DPSCAT | DPORRES | DPORRESU | DPSTRESC | DPSTRESN | DPSTRESU | DPCOLSRT |
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1 | | DP | CIG01a | | LENGTH | Length | DESIGN PARAMETER SPECIFICATION | mm |
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| TARGET | 2 | TOB07 | DP | CIG01a | 2 | LENGTH | Length | DESIGN PARAMETER SPECIFICATION | mm |
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| MINIMUM | 3 | TOB07 | DP | CIG01a | 3 | LENGTH | Length | DESIGN PARAMETER SPECIFICATION | mm |
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| MAXIMUM | 4 | TOB07 | DP | CIG01a | 4 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION | mm |
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| TARGET | 5 | TOB07 | DP | CIG01a | 5 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION | mm |
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| MINIMUM | 6 | TOB07 | DP | CIG01a | 6 | CIRCUMF | Circumference | DESIGN PARAMETER SPECIFICATION | mm |
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| MAXIMUM | 7 | TOB07 | DP | CIG01a | 7 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg |
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| TARGET | 8 | TOB07 | DP | CIG01a | 8 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg |
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| MINIMUM | 9 | TOB07 | DP | CIG01a | 9 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER SPECIFICATION | mg |
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| MAXIMUM | 10 | TOB07 | DP | CIG01a | 10 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % |
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| TARGET | 11 | TOB07 | DP | CIG01a | 11 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % |
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| MINIMUM | 12 | TOB07 | DP | CIG01a | 12 | MOISTURE | Moisture | DESIGN PARAMETER SPECIFICATION | % |
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| MAXIMUM | 13 | TOB07 | DP | CIG01a | 13 | TOCUTSIZ | Tobacco Cut Size |
| mm or cuts per inch 2 |
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| TARGET | 14 | TOB07 | DP | CIG01a | 14 | TOCUTSIZ | Tobacco Cut Size |
| mm or cuts per inch 2 |
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| MINIMUM | 15 | TOB07 | DP | CIG01a | 15 | TOCUTSIZ | Tobacco Cut Size |
| mm or cuts per inch 2 |
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| MAXIMUM | 16 | TOB07 | DP | CIG01a | 16 | FLTRVENT | Filter Ventilation |
| % |
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| TARGET | 17 | TOB07 | DP | CIG01a | 17 | FLTRVENT | Filter Ventilation |
| % |
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| MINIMUM | 18 | TOB07 | DP | CIG01a | 18 | FLTRVENT | Filter Ventilation |
| % |
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| MAXIMUM | 19 | TOB07 | DP | CIG01a | 19 | TPNPLGTH | Tipping Paper Length |
| mm |
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| TARGET | 20 | TOB07 | DP | CIG01a | 20 | TPNPLGTH | Tipping Paper Length |
| mm |
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| MINIMUM | 21 | TOB07 | DP | CIG01a | 21 | TPNPLGTH | Tipping Paper Length |
| mm |
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| MAXIMUM | 22 | TOB07 | DP | CIG01a | 22 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability |
| CORESTA Unit (Cu) |
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| TARGET | 23 | TOB07 | DP | CIG01a | 23 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability |
| CORESTA Unit (Cu) |
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| MINIMUM | 24 | TOB07 | DP | CIG01a | 24 | CIGBPPOR | Cigarette Base Paper Porosity or Permeability |
| CORESTA Unit (Cu) |
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| MAXIMUM | 25 | TOB07 | DP | CIG01a | 25 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity |
| CORESTA Unit (Cu) or cm2/s |
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| TARGET | 26 | TOB07 | DP | CIG01a | 26 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity |
| CORESTA Unit (Cu) or cm2/s |
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| MINIMUM | 27 | TOB07 | DP | CIG01a | 27 | BNDDIF | Cigarette Paper Band Porosity or Permeability or Band Diffusivity |
| CORESTA Unit (Cu) or cm2/s |
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| MAXIMUM | 28 | TOB07 | DP | CIG01a | 28 | CPBNDWID | Cigarette Paper Band Width |
| mm |
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| TARGET | 29 | TOB07 | DP | CIG01a | 29 | CPBNDWID | Cigarette Paper Band Width |
| mm |
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| MINIMUM | 30 | TOB07 | DP | CIG01a | 30 | CPBNDWID | Cigarette Paper Band Width |
| mm |
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| MAXIMUM | 31 | TOB07 | DP | CIG01a | 31 | CPBNDSPC | Cigarette Paper Band Space |
| mm |
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| TARGET | 32 | TOB07 | DP | CIG01a | 32 | CPBNDSPC | Cigarette Paper Band Space |
| mm |
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| MINIMUM | 33 | TOB07 | DP | CIG01a | 33 | CPBNDSPC | Cigarette Paper Band Space |
| mm |
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| MAXIMUM | 34 | TOB07 | DP | CIG01a | 34 | FLTREFF | Filter Efficiency |
| % |
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| TARGET | 35 | TOB07 | DP | CIG01a | 35 | FLTREFF | Filter Efficiency |
| % |
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| MINIMUM | 36 | TOB07 | DP | CIG01a | 36 | FLTREFF | Filter Efficiency |
| % |
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| MAXIMUM | 37 | TOB07 | DP | CIG01a | 37 | DPF | Denier Per Filament |
| /filament |
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| TARGET | 38 | TOB07 | DP | CIG01a | 38 | DPF | Denier Per Filament |
| /filament |
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| MINIMUM | 39 | TOB07 | DP | CIG01a | 39 | DPF | Denier Per Filament |
| /filament |
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| MAXIMUM | 40 | TOB07 | DP | CIG01a | 40 | DENIER | Denier |
| g/9000 m |
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| TARGET | 41 | TOB07 | DP | CIG01a | 41 | DENIER | Denier |
| g/9000 m |
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| MINIMUM | 42 | TOB07 | DP | CIG01a | 42 | DENIER | Denier |
| g/9000 m |
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| MAXIMUM | 43 | TOB07 | DP | CIG01a | 43 | FLTRDEN | Filter Density |
| g/cm3 |
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| TARGET | 44 | TOB07 | DP | CIG01a | 44 | FLTRDEN | Filter Density |
| g/cm3 |
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| MINIMUM | 45 | TOB07 | DP | CIG01a | 45 | FLTRDEN | Filter Density |
| g/cm3 |
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| MAXIMUM | 46 | TOB07 | DP | CIG01a | 46 | FLTRLGTH | Filter Length |
| mm |
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| TARGET | 47 | TOB07 | DP | CIG01a | 47 | FLTRLGTH | Filter Length |
| mm |
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| MINIMUM | 48 | TOB07 | DP | CIG01a | 48 | FLTRLGTH | Filter Length |
| mm |
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| MAXIMUM | 49 | TOB07 | DP | CIG01a | 49 | FLTPRDRP | Filter Pressure Drop |
| mm H2O |
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| TARGET | 50 | TOB07 | DP | CIG01a | 50 | FLTPRDRP | Filter Pressure Drop |
| mm H2O |
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| MINIMUM | 51 | TOB07 | DP | CIG01a | 51 | FLTPRDRP | Filter Pressure Drop |
| mm H2O |
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| MAXIMUM | 52 | TOB07 | DP | CIG01a | 52 | TORODDEN | Tobacco Rod Density |
| g/cm3 |
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| TARGET | 53 | TOB07 | DP | CIG01a | 53 | TORODDEN | Tobacco Rod Density |
| g/cm3 |
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| MINIMUM | 54 | TOB07 | DP | CIG01a | 54 | TORODDEN | Tobacco Rod Density |
| g/cm3 |
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| MAXIMUM | 55 | TOB07 | DP | CIG01a | 55 | Cigarette Paper Length | CIGPLGTH |
| mm |
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| TARGET | 56 | TOB07 | DP | CIG01a | 56 | Cigarette Paper Length | CIGPLGTH |
| mm |
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| MINIMUM | 57 | TOB07 | DP | CIG01a | 57 | Cigarette Paper Length | CIGPLGTH |
| mm |
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