| Shareqc_sdtmig34_ds |
|---|
| 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 |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req | | DOMAIN | Domain Abbreviation | Char | TCES | Identifier | Two-character abbreviation for the domain. | Req | | STOCONID | Sponsor-defined Storage Conditions ID | 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. If a published standard set of conditions is used, the value should represent that (e.g., "E-Liquid Standard Long Term ConditionConditions"). If the study sponsor creates their own set of storage conditions, or modifies a standard set, the value should reflect that (e.g., "Modified E-Liquid Standard Long Term Conditions"). 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) the set of storage conditions represent by STOCONID within the dataset. | Req | | ESPARMCD | Tobacco Product ID Storage Conditions Element Short Name | Char | PARMCDTOPARMCDES | Topic | Short name of the identifier or descriptor being described. Examples: "MANUFTEMP", "TRADENAM", "CIRCUMFHUMID". | Req | | ESPARM | Tobacco Product ID Element Name | Char | PARMTOPARMES | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "ManufacturerTemperature", "Trade Name", "CircumferenceHumidity". | Req | | ESVAL | Tobacco Product ID Element Value | Char | * | Result Qualifier | Value for the parameter in TOPARMCDESPARMCD/TOPARM for the product ESPARM for a condition within a set of conditions identified by SPTOBIDSTOCONID. | 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")ESVAL. Must be used where applicable (e.g., "Circumference")when the parameter has units. | 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. |