| 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 | 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 | | ITSPECIF | Specification or Variety of Tobacco Ingr | Char |
| Variable Qualifier | A qualifier of INGCMPID. Used to represent the specification (variety) of tobacco ingredient (e.g., "USDA Nicotiana Collection PI 552747", "KT215LC"). | Exp | | ITCAT | Category of Tobacco Ingredient | Char | SINGLE INGREDIENT, COMPLEX INGREDIENT | 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., "Air", "Sun", "Flue"). | Exp | | ITCPISP | Complex Ingredient Customized Indicator | 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. | Perm | | TPMF | Tobacco Product Master File ID | Char |
| Identifier | A reference to the 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. |