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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.TOBA-740
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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.
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
Char
Result Qualifier
Value for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID.
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").