SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist or Format1
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
Sponsor-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.
Req
TOPARMCD
Tobacco Product ID Element Short Name
Char
(PARMCDTO)
Topic
Short name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".
Req
TOPARM
Tobacco Product ID Element Name
Char
(PARMTO)
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
(CATTO)
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").
Content: For variable TOPARMCD, codelist PARMCDTO is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable TOPARM, codelist PARMTO is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
Content: For variable TOCAT, codelist CATTO is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.