| Shareqc_sdtmig34_ds |
|---|
| Class | Special Purpose |
|---|
| Domain | PD |
|---|
| | 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 | PD | 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 must be unique for each unique tobacco product as defined by the specific values of the product's PDPARMCD-PDVAL pairs. | Req | | PDSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a design parameter within a tobacco product (SPTOBID) within the dataset. | Req | | PDPARMCD | Design Parameter Element Short Name | Char | PARMCDPD | Topic | Short name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC". | Req | | PDPARM | Design Parameter Element Name | Char | PARMPD | Synonym Qualifier | Name of the parameter being described. Examples: "Tobacco Cut Size", "Battery Capacity". | Req | | PDVALTRG | Design Parameter Element Target Value | Char | * | Result Qualifier | Target value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Req | | PDVALMIN | Design Parameter Element Minimum Value | Char |
| Result Qualifier | Minimum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Exp | | PDVALMAX | Design Parameter Element Maximum Value | Char |
| Result Qualifier | Maximum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID. | Exp | | PDVALU | Design Parameter Element Value Unit | Char | UNIT | Result Qualifier | The single unit for the values in PDVALTRG, PDVALMIN and PDVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). 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. |