The IT example| Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-310 |
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below example below shows tobacco filler and the types of tobacco of which it is composed, each listed as tobacco ingredients in the variable IGDCMPID (ingredient or component identifier) for the Tobacco Product CIG01A (SPTOBID). The variable ITSPECIF shows the specification/variety of the first three tobaccos. ITIGDPLX (Ingredient Complexity) is used to indicate that the Tobacco Filler and the Reconstituted Tobacco are complex ingredients (they both have two or more subcomponents). The details of which single tobacco ingredients compose these complex ingredients is made explicit in the IQ dataset example further down. ITCURMTH indicates the cure method. ITCIGIND (applicant-customized ingredient indicator) is used to indicate whether complex ingredients were made to the applicant's specification. TPMF indicates the Tobacco Product Master File name/number, which should be provided in the data if the component manufacturer has made it available.| Jira |
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85506ce4-3cb3-3d91-85ee-f633aaaf4a45 | | key | TOBA-307 |
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Note that there are two varieties of burley tobacco in this tobacco product, thus each is given a unique IGDCMPID value (Burley Tobacco and Burley Tobacco 2).
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The IN dataset example below shows the list of non-tobacco ingredients
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-112 |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-106 |
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used ingredients used in the tobacco product identified as CIG01A. Each unique ingredient is listed in IGDCMPID
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-304 |
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. Where applicable, IUPAC name and CAS
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-305 |
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number are listed (IUPACNAM and CASNO variables, respectively). INIGDPLX is used to indicate whether an ingredient is a single ingredient or a complex ingredient.
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-306 |
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INCIGIND | Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-311 |
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indicates INCIGIND indicates whether complex ingredients were made to the applicant's specification. Grade, purity, manufacturer name, ingredient unique item number, and the Tobacco Product Master File number complete the dataset.
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Finally, the IQ domain is used to represent the quantity (target, minimum and maximum) of each ingredient identified in IGDCMPID that the product (SPTOBID) is designed to contain, with the units for these values represented in IQUNIT. The function of each ingredient is described in IQFUNCT. Ingredients that appear in more than one component of the tobacco product are quantified separately for each component. IQPARENT identifies a component or complex ingredient composed of the subcomponents/ingredients shown in IDGCMPID. IQLEVEL is used to identify at what level
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-240 |
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in level in the overall hierarchy that subcomponent/ingredient appears.
The following implementation rules apply, as described in more detail under the "Assumptions" subheading in section 2.8.8.6, SDTM Ingredient Quantities by Component (IQ):
- IQPARENT must correspond to a value of IGDCMPID in the same dataset.
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-313 |
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If If parent is null, the ingredient is considered a top-level component and is assigned an IQLEVEL value of "1". - Records describing subcomponents/ingredients that compose a parent component listed in the dataset will have IQPARENT value equal to the IGDCMPID of that parent component. IQLEVEL will be set to n +1, where n=the parent record's value of IQLEVEL
- Every value of IGDCMPID used in the IQ dataset must have a matching value of IGDCMPID:
- In the IT dataset (when IQCAT=TOBACCO INGREDIENT) or,
- In the IN dataset (when IQCAT=NON-TOBACCO INGREDIENT)
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The use of IQPARENT and IQLEVEL help make explicit the relationship between complex ingredients or components and the subcomponents/ingredients of which they are composed, and can assist when totaling the quantities of an ingredient that appears in multiple components of a tobacco product.
The concept map below illustrates the representation of the hierarchical relationships between a component and its subcomponents/ingredients in the IQ domain structure.
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server | Issue Tracker (JIRA)| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-239 |
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| Excerpt Include |
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| Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ |
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| Concept Map. Relationships of Components, Subcomponents and Ingredients in IQ |
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| Dataset wrap |
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| Rows 1, 13, 16: | Show three top-level components of a cigarette product: tobacco filler, filter, and cigarette paper, respectively. Their target, minimum and maximum quantities expressed in units of mg/cigarette are shown in IQVALTRG, IQVALMIN, IQVALMAX and IQUNIT. Because there is no parent component other than the finished product itself, IQPARENT is null, and IQLEVEL = 1, indicating that these are top-level ingredients/components of the finished product. | | Rows 2-5: | Show the quantities of four types of tobacco used in the product. IQPARENT=Tobacco Filler and IQLEVEL=2, together indicating that these are subcomponents/ingredients in the tobacco filler, a top level-component of the cigarette product. | | Rows 6-8: | Show the three tobacco ingredients that compose reconstituted tobacco in row 5 (IQPARENT=Reconstituted Tobacco). The quantities of these tobaccos pertain to the quantity at which they appear in the reconstituted tobacco ONLY. IQLEVEL=3 to show that these ingredients are at the 3rd level of the hierarchy (subcomponents/ingredients in Reconstituted Tobacco, which has IQLEVEL=2). Therefore, the total quantity of the individual tobaccos used in this tobacco product is the sum of these three rows plus the sum of the quantities shown in rows 2-4. | | Rows 9-10: | Show the quantities of two non-tobacco ingredients, Methylcellulose and 1,3-Butanediol, which are further subcomponents/ingredients in Reconstituted Tobacco, as indicated by IQPARENT. IQFUNCT shows that Methylcellulose functions as a binder and 1,3-Butanediol functions as a humectant. IQLEVEL=3 to show that these ingredients are at the 3rd level of the hierarchy. | | Rows 11-12: | Show the quantities of two subcomponents/ingredients that both function as a flavorant in the tobacco filler| Jira |
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| key | TOBA-320 |
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filler (as indicated by IQFUNCT= Flavor and IQPARENT=Tobacco Filler). | | Rows 14-15: | Show the quantities of two subcomponents/ingredients that function as filtration and plasticizer, respectively, in the filter portion of the cigarette (Cellulose Filter A| Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | TOBA-319 |
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, a top-level component shown in row 13). | | Rows 17-22: | Show the quantities and functions of six subcomponents/ingredients in the top-level component FSC Paper B (the cigarette paper shown in row 16). |
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| Row | DOMAIN | STUDYID | SPTOBID | IGDCMPID | IQCAT | IQPARENT | IQLEVEL | IQFUNCT | IQVALTRG | IQVALMIN | IQVALMAX | IQUNIT |
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| 1 | IQ | TOB07 | CIG01A | Tobacco Filler | TOBACCO INGREDIENT |
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| 672.5 | 661.3 | 683.7 | mg/cigarette | | 2 | IQ | TOB07 | CIG01A | Burley Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 19 | 17 | 21 | mg/cigarette | | 3 | IQ | TOB07 | CIG01A | Bright Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 300 | 295 | 305 | mg/cigarette | | 4 | IQ | TOB07 | CIG01A | Oriental Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 115 | 113 | 117 | mg/cigarette | | 5 | IQ | TOB07 | CIG01A | Reconstituted Tobacco | TOBACCO INGREDIENT | Tobacco Filler | 2 |
| 231 | 229 | 233 | mg/cigarette | | 6 | IQ | TOB07 | CIG01A | Burley Tobacco 2 | TOBACCO INGREDIENT | Reconstituted Tobacco | 3 |
| 19 | 18 | 20 | mg/cigarette | | 7 | IQ | TOB07 | CIG01A | Bright Tobacco | TOBACCO INGREDIENT | Reconstituted Tobacco | 3 |
| 103 | 101 | 105 | mg/cigarette | | 8 | IQ | TOB07 | CIG01A | Oriental Tobacco | TOBACCO INGREDIENT | Reconstituted Tobacco | 3 |
| 65 | 63 | 67 | mg/cigarette | | 9 | IQ | TOB07 | CIG01A | Methylcellulose | NON-TOBACCO INGREDIENT | Reconstituted Tobacco | 3 | Binder | 20 | 19 | 21 | mg/cigarette | | 10 | IQ | TOB07 | CIG01A | 1,3-Butanediol | NON-TOBACCO INGREDIENT | Reconstituted Tobacco | 3 | Humectant | 24 | 23 | 25 | mg/cigarette | | 11 | IQ | TOB07 | CIG01A | Cocoa Extract | NON-TOBACCO INGREDIENT | Tobacco Filler | 2 | Flavor | 7 | 6.75 | 7.25 | mg/cigarette | | 12 | IQ | TOB07 | CIG01A | Butyric Acid | NON-TOBACCO INGREDIENT | Tobacco Filler | 2 | Flavor | 0.5 | 0.55 | 0.45 | mg/cigarette | | 13 | IQ | TOB07 | CIG01A | Cellulose Filter A | NON-TOBACCO INGREDIENT |
| 1 | Filter | 164 | 163 | 165 | mg/cigarette | | 14 | IQ | TOB07 | CIG01A | Cellulose Acetate | NON-TOBACCO INGREDIENT | Cellulose Filter A | 2 | Filtration | 155 | 154 | 156 | mg/cigarette | | 15 | IQ | TOB07 | CIG01A | Triacetin | NON-TOBACCO INGREDIENT | Cellulose Filter A | 2 | Plasticizer | 9 | 8 | 10 | mg/cigarette | | 16 | IQ | TOB07 | CIG01A | FSC Paper B | NON-TOBACCO INGREDIENT |
| 1 | Cigarette Paper (Wrapper) | 50 | 49 | 51 | mg/cigarette | | 17 | IQ | TOB07 | CIG01A | Cellulose Pulp | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Fiber | 30 | 29 | 31 | mg/cigarette | | 18 | IQ | TOB07 | CIG01A | Calcium Carbonate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Filler | 15 | 14 | 16 | mg/cigarette | | 19 | IQ | TOB07 | CIG01A | Sodium Alginate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Reduced ignition propensity | 2 | 1.75 | 2.25 | mg/cigarette | | 20 | IQ | TOB07 | CIG01A | Trisodium Citrate | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Combustion Modifier | 0.5 | 0.45 | 0.55 | mg/cigarette | | 21 | IQ | TOB07 | CIG01A | Cationic Starch | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Binder | 0.5 | 0.45 | 0.55 | mg/cigarette | | 22 | IQ | TOB07 | CIG01A | Seam Adhesive | NON-TOBACCO INGREDIENT | FSC Paper B | 2 | Adhesive | 2 | 1.75 | 2.25 | mg/cigarette |
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