| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | 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 | Applicant-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 |
| Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a 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 IGDCMPID. Does not need to be populated for single ingredients. | Perm |
| INMANUIN | Manufacturer Unique Identifying Item Num | Char |
| Identifier | The unique 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 IGDCMPID, if applicable. | Exp |
| CASNO | | Char | | 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 IGDCMPID. | Perm |
| INIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether an ingredient is a single or complex ingredient (i.e.,., "SINGLE INGREDIENT", "COMPLEX INGREDIENT"). | Exp |
| INCIGIND | Applicant-Customized Ingredient Indic | Char | (NY) | Record Qualifier | Used to indicate whether a complex ingredient was made to the applicant's specification. Expected to be populated where INIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
| INGRADE | Ingredient Grade | Char | | Record Qualifier | The grade of the ingredient represented in IGDCMPID (e.g., "USP", "FOOD"). | Exp |
| INPURITY | Ingredient Purity | Char |
| Record Qualifier | The purity of the ingredient represented in IGDCMPID, provided for any ingredient for which this information is available (e.g., "99%", ">99%"). | Exp |