| 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 | IT | 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 |
| IGDCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product. In INIT, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco"). | Req |
| TPMF | Tobacco Product Master File ID | Char |
| Identifier | The Tobacco Product Master File number, if applicable. | Perm |
| ITSPECIF | Specification or Variety of Tobacco Ingr | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-308 |
|---|
|
| Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-201 |
|---|
|
| Char |
| Variable Qualifier | A qualifier of INGCMPIDIGDCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC"). | Exp |
| ITIGDPLX | Ingredient Complexity | Char | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient (i.e.g., "SINGLE INGREDIENT" , or "COMPLEX INGREDIENT"). | Exp |
| ITCIGIND | Applicant-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 ITIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
| ITCURMTH | Cure Method | Char* |
| Record Qualifier | Method by which the tobacco ingredient is cured (e.g., "Air", "Sun", "Flue"). | Exp |
| ITSPFL | Complex Ingredient Specification Flag | Char | (NY) | Record Qualifier | Used to indicate whether a complex tobacco ingredient was made to the applicant's specification. Expected to be populated where ITCAT = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
TPMF | Tobacco Product Master File ID | Char | Identifier | The Tobacco Product Master File number, if applicable. | Perm |