| Shareqc_sdtmig34_ds |
|---|
| Class | Study Reference |
|---|
| Domain | TO |
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| | 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 | TO | 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. It must be unique for each unique tobacco product as defined by the specific values of the product's TOPARMCD-TOVAL pairs. | Req | | TOSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset. | Req | | TOPARMCD | Tobacco Product ID Element Short Name | Char | (PARMCDTO) | Topic | Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF". | Req | | TOPARM | Tobacco Product ID Element Name | Char | (PARMTO) | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference". | Req | | TOCAT | Category of Tobacco Product ID Element | Char | (CATTO) | Grouping Qualifier | Used to define a category of records based on whether the product is new or a predicate product. Values restricted to "NEW PRODUCT" and "PREDICATE PRODUCT". | Req | | TOSCAT | Subcategory of Tobacco Prod ID Element | Char |
| Grouping Qualifier | Used to define a sub-category of related records (e.g., TOBACCO PRODUCT IDENTIFIERSIDENTIFIER, TOBACCO PRODUCT DESCRIPTORSDESCRIPTOR). | Perm | | TOVAL | Tobacco Product ID Element Value | Char | * | Result Qualifier | Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID. | Req | | TOVALU | Tobacco Product ID Element Value Unit | Char | (UNIT) | Result Qualifier | Unit for the value in TOVAL. Will be blank for unitless identifying descriptors (e.g., "Trade Name"). Must be used where applicable (e.g., "Circumference"). | 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. |