Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication.
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.
Req
DOMAIN
Domain Abbreviation
Char
TO
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. 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.
Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".
Req
TOPARM
Tobacco Product ID Element Name
Char
(TOPARM)
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
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
(UNIT)
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").