| Shareqc_sdtmig34_ds |
|---|
| Class | Special Purpose |
|---|
| Domain | IT |
|---|
| | 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 | IT | Identifier | Two-character abbreviation for the domain. | Req | | SPTOBID | Sponsor-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 IN, it must be a tobacco ingredient of the product represented in SPTOBID (e.g., "Burley Tobacco", "Reconstituted Tobacco"). | Req | | ITSPECIF | Specification or Variety of Tobacco Ingr | 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 (e.g., "SINGLE INGREDIENT", "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 |
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1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses. |