| 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 | 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 IT, 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 |
| ITCATITIGDPLX | Category of Tobacco Ingredient Complexity | CharSINGLE INGREDIENT, COMPLEX INGREDIENT | (IGDCMPLX) | Grouping Qualifier | Used to denote whether a tobacco ingredient is a single or complex ingredient . | Exp | ITCURMTH | Cure Method | Char | * | Record Qualifier | Method by which the tobacco ingredient is cured (e.g(i.e., "AirSINGLE INGREDIENT" , "Sun", "Flueor "COMPLEX INGREDIENT"). | Exp |
| ITSPFLITCIGIND | Complex Ingredient Specification FlagApplicant-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 ITCAT ITIGDPLX = COMPLEX INGREDIENT. Values restricted to "Y" or "N". | Perm |
| ITCURMTH | Cure Method | TPMF | Tobacco Product Master File ID | Char | Identifier | The Tobacco Product Master File number, if applicable. | Perm |