| 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 | IN | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | SponsorApplicant-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 |
| 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 INGCMPIDIGDCMPID. Does not need to be populated for single ingredients. | Perm |
| INMANUFNINMANUIN | Registration NumberUnique Identifying Item Num | Char |
| Identifier | registration number of the manufacturer of a complex ingredient/component represented in INGCMPID. Does not need to be populated for single ingredientsunique identifying item number assigned by the manufacturer to the ingredient or component shown in IGDCMPID (e.g, catalog number). | Perm |
| Tobacco Product Master File Number | Char |
| Identifier | The Tobacco Product Master File number for the ingredient/component represented in IGDCMPID, if applicable. Used for proprietary purchased ingredients when the manufacturer does not want to disclose the formula to the public and has instead provided these details in a file directly to regulators. | Perm |
| IUPACNAM | Preferred IUPAC Name | Char | | Identifier | The preferred International Union of Pure and Applied Chemistry (IUPAC) name of the ingredient represented in INGCMPIDIGDCMPID, if applicable. | Exp |
| CASNO | | Char | CAS | Identifier | The Chemical Abstract Service (CAS) registry number for the ingredient represented in IGDCMPID. | Perm |
| Unique Ingredient Identifier | Char | UNII | Identifier | The FDA Unique Ingredient Identifier (UNII) number for the ingredient represented in INGCMPID, if applicableIGDCMPID. | ExpPerm |
| INCATINIGDPLX | Category of Tobacco Ingredient Complexity | CharSINGLE INGREDIENT, COMPLEX INGREDIENT | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a tobacco an ingredient is a single or complex ingredient (i.e.,., "SINGLE INGREDIENT", "COMPLEX INGREDIENT"). | Exp |
| INSPFLINCIGIND | Complex Ingredient Customized IndicatorApplicant-Customized Ingredient Indic | 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 INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
| INGRADE | Ingredient Grade | Char | | Record Qualifier | The grade of the ingredient represented in INGCMPID IGDCMPID (e.g., "USP", "FOOD"). | Exp |
| INPURITY | Ingredient Purity | Char |
| Record Qualifier | The purity of the ingredient represented in INGCMPID IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%"). |