| 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 | IN | 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 PDPARMCD-PDVAL 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 |
| INMANUF | Manufacturer Name | Char |
| Identifier | The name of the manufacturer of a complex ingredient/component represented in INGCMPID. Does not need to be populated for single ingredients. | Perm |
| INMANUFN | Manufacturer Registration Number | Char |
| Identifier | The registration number of the manufacturer of a complex ingredient/component represented in INGCMPID. Does not need to be populated for single ingredients. | Perm |
| TPMF | Tobacco Product Master File Number | Char |
| Identifier | The Tobacco Product Master File number for the ingredient/component represented in INGCMPID, if applicable. | Perm |
| IUPACNAM | IUPAC Name | Char | IUPAC | Identifier | The preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in INGCMPID, if applicable. | Exp |
| CASNO | CAS Registry Number | Char | CAS | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient represented in INGCMPID, if applicable. | Exp |
| 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 |
| INSPFL | 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 |
| INGRADE | Grade | Char |
| Record Qualifier | The grade of the ingredient represented in INGCMPID (e.g., "FOOD") |
|
| INPURITY | Purity | Char |
| Record Qualifier | The purity of the ingredient represented in INGCMPID (e.g., "99%", ">99%"). |
|