| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. Serves as a key to indicate that all datasets containing the same value of this variable are related by the purpose for which they were collected. | Req |
| DOMAIN | Domain Abbreviation | Char | PD | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | Applicant-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 |
| IGDCMPID | Ingredient or Component Identifier | Char |
| Identifier | Identifier given to an ingredient, substance or component of a tobacco product .(e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PD assumption 7 2 below for more info. | Perm |
| 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 | (PARMCDPDPDPARMCD) | 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 |