| Shareqc_sdtmig34_ds |
|---|
| Class | Study Reference |
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| Domain | TO |
|---|
| | 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 | 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 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 | | 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. |