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TO – Description/Overview

TO – Specification

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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 AbbreviationCharTOIdentifierTwo-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. 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(PARMCDTO)TopicShort name of the identifier or descriptor being described. Examples: "MANUF", "TRADENAM", "CIRCUMF".Req
TOPARMTobacco Product ID Element NameChar(PARMTO)Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "Manufacturer", "Trade Name", "Circumference".Req
TOVALTobacco Product ID Element ValueChar*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

Metadata Checks Findings

SDTMIG v3.3 Metadata Check User Macros FAQ
  • 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

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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