shareqc_sdtmig34sdtm4tig10_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 | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier. | 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. |