| 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 | 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 PDPARMCDIQPARMCD-PDVAL IQVAL pairs. | Req |
| INGCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product. In IN, it must be a non-tobacco ingredient of the product represented in SPTOBID (e.g., "Cocoa Extract", "Cellulose Pulp"). | Req |
| INCAT | Category of Tobacco Ingredient | Char | SINGLE INGREDIENT, COMPLEX INGREDIENT | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient. | Exp |
| IQPARENT | Complex Ingredient Customized Indicator | Char | (NY) | Record Qualifier | Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where INCAT = COMPLEX INGREDIENT. | Perm |
| IQLEVEL | Grade | Char |
| Record Qualifier | The grade of the ingredient represented in INGCMPID (e.g., "FOOD") |
|
| IQFUNCT | Purity | Char |
| Record Qualifier | The purity of the ingredient represented in INGCMPID (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 |