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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
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharPDIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDApplicant-Defined Tobacco Product IDChar
IdentifierIdentifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. In product description studies (i.e., where there are no human subjects) it is the top-level identifier.Req
IGDCMPIDIngredient or Component IdentifierChar
IdentifierIdentifier given to an ingredient, substance or component of a tobacco product .(e.g., "Burley Tobacco", "Reconstituted Tobacco"). It originates in the IT or IN domain. See PD assumption 2 below for more info.Perm
PDSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a design parameter within a tobacco product (SPTOBID) within the dataset.Req
PDPARMCDDesign Parameter Element Short NameChar(PDPARMCD)TopicShort name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC".Req
PDPARMDesign Parameter Element NameChar

(PDPARM) TOBA-573 - Getting issue details... STATUS

Synonym QualifierName of the parameter being described. Examples: "Tobacco Cut Size", "Battery Capacity".Req
PDVALTRGDesign Parameter Element Target ValueChar
Result QualifierTarget value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Req
PDVALMIN

Design Parameter Element Minimum Value

Char
Result QualifierMinimum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Exp
PDVALMAX

Design Parameter Element Maximum Value

Char
Result QualifierMaximum allowable value, according to the manufacturer's design specifications, for the parameter in PDPARMCD/PDPARM for the product identified by SPTOBID.Exp
PDVALUDesign Parameter Element Value UnitChar(UNIT)Result QualifierThe single unit for the values in PDVALTRG, PDVALMIN and PDVALMAX. Will be blank for unitless parameters (e.g., "Number of Heating Elements"). Must be used where applicable (e.g., "Circumference").Perm
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