| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req |
| DOMAIN | Domain Abbreviation | Char | IQ | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | SponsorApplicant-Defined Tobacco Product ID | Char |
| Identifier | Sponsor-defined identifier for a Tobacco Product. SPTOBID should be populated with an intuitive name based on a description of the tobacco product (e.g., "CIG104"; "ENDS01A", etc). It must be unique for each unique tobacco product as defined by the specific values of the product's IQPARMCD-IQVAL pairs. | Req | 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 |
| IGDCMPIDINGCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product represented in SPTOBID. In INIQ, it must be match a value of IGDCMPID in either the IT dataset (if the ingredient is a tobacco ingredient) or IN (if the ingredient is a non-tobacco ingredient of the product represented in SPTOBID ). (e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp"). | Req |
| INCATIQCAT | Category of Tobacco IngredientIngredient or Component | Char | | Grouping Qualifier | Used to group ingredients/components by tobacco and non-tobacco ingredients. Required to enable conformance checks to ensure IGDCMPID is present in either the IT or IN domain. | Req |
| IQIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Char | SINGLE INGREDIENT, COMPLEX INGREDIENT | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient (e.g., "SINGLE INGREDIENT", "COMPLEX INGREDIENT"). | Exp |
| Complex Ingredient Customized IndicatorParent of Ingredient or Component | Char(NY) |
| Record QualifierUsed | to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where INCAT = COMPLEX INGREDIENT Identifies the parent of which the ingredient or component represented in IGDCMPID is a part. (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. IQPARENT will therefore always be a complex ingredient. 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 | Grade | Ingredient Level in Hierarchy | NumChar |
| Record Qualifier | An integer that identifies the level of the ingredient or component 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. | Req |
| IQFUNCT | Ingredient Function | The grade of the ingredient represented in INGCMPID (e.g., "FOOD") | IQFUNCT | Purity | Char |
| Record Qualifier | The purity function of the ingredient represented in INGCMPID in the tobacco product or the parent component. (e.g., "99%Adhesive", ">99%Flavorant"). | Exp |
| IQVALTRG | Design Parameter Element Ingredient Target Value | CharNum | * |
| Result Qualifier | Target value , (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. 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 | Design Parameter Element Ingredient Minimum Value | CharNum |
| Result Qualifier | Minimum allowable value, value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. If the ingredient appears in multiple components of the tobacco product, IQVALMIN represents the minimum quantity within the parent component. | Exp |
| IQVALMAX | Design Parameter Element Ingredient Maximum Value | CharNum |
| Result Qualifier | Maximum allowable value, value (quantity) of the ingredient shown in IGDCMPID according to the manufacturer's ingredient design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. If the ingredient appears in multiple components of the tobacco product, IQVALMAX represents the maximum quantity within the parent component. | Exp |
| IQVALU | Design Parameter Element Ingredient Value Unit | Char | (UNIT) | Result Qualifier | The single unit for the values in IQVALTRG, IQVALMIN and IQVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference"). | Perm |