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SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharPDIdentifierTwo-character abbreviation for the domain.Req
SPTOBIDSponsor-Defined Tobacco Product IDChar
IdentifierIdentifier used to uniquely identify a tobacco product across all studies for all applications/submissions involving the product. Identifier 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
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(PARMCDPD)TopicShort name of the parameter being described. Examples: "TOCUTSIZ", "BATCAPC".Req
PDPARMDesign Parameter Element NameChar(PARMPD)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

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • Content: For variable PDPARMCD, codelist PARMCDPD is a not a recognized SDTM CT short name; or, does not confirm to the convention for specifying codelist
  • Content: For variable PDPARM, codelist PARMPD 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.

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