Shareqc_sdtmig34_ds |
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Class | Study Reference |
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Domain | TC |
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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. | Req | DOMAIN | Domain Abbreviation | Char | TC | Identifier | Two-character abbreviation for the domain. | Req | STOCONID |
| Char |
| Identifier | Sponsor-defined identifier for representing a set of storage conditions. STOCONID should be populated with an intuitive name based on a description of the storage conditions (e.g., "E-Liquid Standard Long Term Condition). It must be unique for each unique set of storage conditions as defined by the specific values of the condition's TOPARMCD-TOVAL pairs. | Req | ESSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset. | Req | ESPARMCD | Tobacco Product ID Element Short Name | Char | PARMCDTO | Topic | Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF". | Req | ESPARM | Tobacco Product ID Element Name | Char | PARMTO | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference". | Req | ESVAL | Tobacco Product ID Element Value | Char | * | Result Qualifier | Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID. | Req | ESVALU | 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. |