| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | IQ | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | Sponsor-Defined Tobacco Product ID | Char |
| Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | Req |
| IGDCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In IQ, it must match a value of IDGCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient). (e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp"). | Req |
| IQIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT") | Exp |
| IQPARENT | Parent of Ingredient or Component | Char |
| Record Qualifier | Identifies the parent of which the ingredient or component represented in IGDCMPID is a constituent. (i.e, IGDCMPID is a child of the ingredient shown in IQPARENT). IQPARENT must equal a value of IGDCMPID from another record in the same dataset. If the ingredient is at the top level (i.e., it has no parent other than the tobacco product itself), IQPARENT will be null and IQLEVEL will be set to 1. (See IQLEVEL, below). | Perm |
| IQLEVEL | Ingredient Level in Hierarchy | Num |
| Record Qualifier | An integer that identifies the level of the ingredient or constituent within the hierarchy. The value of IQLEVEL will be n+1, where n is the IQLEVEL of the parent ingredient. IQLEVEL will be set to 1 If the ingredient is at the top level (i.e., if the ingredient has no parent ingredient/component other than the tobacco product itself). Must be populated when IQPARENT is populated. | Perm |
| IQFUNCT | Ingredient Function | Char |
| Record Qualifier | The function of the ingredient in the tobacco product or the parent component. (e.g., "Adhesive", "Flavorant"). | Exp |
| IQVALTRG | Ingredient Target Value | Num |
| Result Qualifier | Target value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALTRG represents the target quantity within the parent component, not the overall quantity in the tobacco product. | Req |
| IQVALMIN | Ingredient Minimum Value | Num |
| Result Qualifier | Minimum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component. | Exp |
| IQVALMAX | Ingredient Maximum Value | Num |
| Result Qualifier | Maximum value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component. | Exp |
| IQVALU | Ingredient Value Unit | Char | (UNIT) | Result Qualifier | The single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX. | Exp |