| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-740 |
|---|
|
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 | TO | Identifier | Two-character abbreviation for the domain. | Req |
| SPTOBID | Applicant-Defined Tobacco Product | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-532 |
|---|
|
ID | Char | | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-531 |
|---|
|
| Identifier | Identifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. It must be unique for each unique tobacco product as defined by the specific values of the product's TOPARMCD-TOVAL pairs. | Req |
| TOSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset. | Req |
| TOPARMCD | Tobacco Product ID Element Short Name | Char | | Topic | Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF". | Req |
| TOPARM | Tobacco Product ID Element Name | Char | | Synonym Qualifier | Name of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference". | Req |
| TOCAT | Category of Tobacco Product ID Element | Char | (TOCAT) | Grouping Qualifier | Used to define a category of records based on whether the product is new or a predicate product Examples: "NEW PRODUCT", "PREDICATE PRODUCT", "ORIGINAL PRODUCT", and "COMPARISON PRODUCT". | Req |
| TOSCAT | Subcategory of Tobacco Prod ID Element | Char |
| Grouping Qualifier | Used to define a sub-category of related records (e.g., PRODUCT IDENTIFIER, PRODUCT DESCRIPTOR). | Perm |
| TOVAL | Tobacco Product ID Element Value | Jira |
|---|
| showSummary | false |
|---|
| server | Issue Tracker (JIRA) |
|---|
| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
|---|
| key | TOBA-530 |
|---|
|
| Char |
| Result Qualifier | Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID. | Req |
| TOVALU | Tobacco Product ID Element Value Unit | Char | | 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 |