TO – Description/Overview
(will come from content control)
TO – Specification
(will come from content control)
Metadataspec |
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highlight | true | keys | CDISC Notes;Core |
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shareqc_sdtmig34sdtm4tig10_ds |
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Class | Study Reference |
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Domain | TO |
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| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
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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 | TO | 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. 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 | (TOCAT) | Grouping Qualifier | Used to define a category of records based on whether the product is new or a predicate product Examples: "NEW PRODUCT", "PREDICATE PRODUCT", "ORIGINAL PRODUCT", and "COMPARISON PRODUCT". | Req | TOSCAT | Subcategory of Tobacco Prod ID Element | Char |
| Grouping Qualifier | Used to define a sub-category of related records (e.g., PRODUCT IDENTIFIER, PRODUCT DESCRIPTOR). | 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 | | 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 |
| 1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses. |