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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.
SPTOBID... ?SPTOBID - should it be SPTOBID for Sponsor Tobacco Product Identifier???
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| Option 1 of to address Steve H's suggestion of combining our 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. |
| rowcaps | | Rows 1-4: | Show the records for a tobacco product given SPTOBID of CIG01a. | Rows 3-4identifiers that were previously represented in a separate DI dataset | | Rows 5-10: | Show the | tobacco product is a filtered, combusted type of cigarette.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 of 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 | TOSCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU | TOCOLSRT |
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| 1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category |
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| Cigarette |
| Cigarette |
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| | 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory |
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| Filtered, Combusted |
| Filtered, Combusted |
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| | 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer |
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| Joes Cigs USA |
| Joes Cigs USA |
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| | 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name |
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| Treetop Methol Menthol King Size |
| Treetop Methol Menthol King Size |
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| | 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type |
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| HARD PACK |
| HARD PACK |
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| | 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity |
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| 20 | CIGARETTE | 20 | 20 | CIGARETTE |
| | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length |
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| 86.0 | mm | 86.0 | 86.0 | mm |
| | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference |
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| 26.0 | mm | 26.0 | 26.0 | mm |
| | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation |
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| 10.0 | % | 10.0 | 10.0 | % |
| | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor |
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| MENTHOL |
| MENTHOL | 11 | TOB07 | TO | CIG01a | 11 | HTSOURCE | Heat Source | xxx | xxx |
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The Tobacco Product Design Parameters (DP) is (similar to the Device Properties (DO) domain) represents properties 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.
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