| 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 INIQ, it must be 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 of the product represented in SPTOBID ). (e.g., "Burley Tobacco", "Propylene Glycol", "Cocoa Extract", "Cellulose Pulp"). | Req |
| INCATIQIGDPLX | Category of Tobacco Ingredient Complexity | CharSINGLE INGREDIENT, COMPLEX INGREDIENT | (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 INGCMPID ofIGDCMPID 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 | Identifies the generation number An integer that identifies the level of the ingredient or constituent sample is considered the first generationwithin 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). |
|
| IQFUNCT | Purity | Char |
| Record Qualifier | The purity of the ingredient represented in INGCMPID IGDCMPID (e.g., "99%", ">99%"). |
|
| IQVALTRG | Design Parameter Element Target Value | Char | * | Result Qualifier | Target value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. | Req |
| IQVALMIN | Design Parameter Element Minimum Value | Char |
| Result Qualifier | Minimum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. | Exp |
| IQVALMAX | Design Parameter Element Maximum Value | Char |
| Result Qualifier | Maximum allowable value, according to the manufacturer's design specifications, for the parameter in IQPARMCD/IQPARM for the product identified by SPTOBID. | Exp |
| IQVALU | Design Parameter Element 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 |