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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
Identifier

Unique identifier for a study. TOBA-740 - Getting issue details... STATUS 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
DOMAINDomain AbbreviationCharTOIdentifierTwo-character abbreviation for the domain.Req
SPTOBID

Applicant-Defined Tobacco Product ID

Char

TOBA-531 - Getting issue details... STATUS

IdentifierIdentifier 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
TOSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) within the dataset.Req
TOPARMCDTobacco Product ID Element Short NameChar

(TOPARMCD)

TopicShort name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".Req
TOPARMTobacco Product ID Element NameChar

(TOPARM)

Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference".Req
TOCATCategory of Tobacco Product ID ElementChar(TOCAT)Grouping QualifierUsed 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 QualifierUsed to define a sub-category of related records (e.g., PRODUCT IDENTIFIER, PRODUCT DESCRIPTOR).Perm
TOVAL

Tobacco Product ID Element Value TOBA-530 - Getting issue details... STATUS

Char
Result QualifierValue for the parameter in TOPARMCD/TOPARM for the product identified by SPTOBID.Req
TOVALUTobacco Product ID Element Value UnitChar

(UNIT)

Result QualifierUnit 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
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