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Metadataspec
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keysCDISC Notes;Core
shareqc_sdtmig34sdtm4tig10_ds
ClassStudy Reference
DomainTCES
Variable NameVariable LabelTypeControlled Terms, Codelist, or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study. 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 AbbreviationCharTCESIdentifierTwo-character abbreviation for the domain.Req
STOCONIDApplicant-defined Storage Conditions IDChar
IdentifierSponsorApplicant-defined identifier for representing a set of storage conditions. Can also be used in the PT domain where storage conditions of the product being tested are applicable (e.g., stability studies). STOCONID should be populated with an intuitive name based on a description of the storage conditions. If a published standard set of conditions is used, the value should represent that (e.g., "E-Liquid Standard Long Term Conditions"). If the study applicant creates their own set of storage conditions, or modifies a standard set, the value should reflect that (e.g., "Modified E-Liquid Standard Long Term ConditionConditions"). It must be unique for each unique set of storage conditions as defined by the specific values of the condition's TOPARMCD-TOVAL ESPARMCD-ESVAL pairs.Req
ESSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter within a tobacco product (SPTOBID) the set of storage conditions represent by STOCONID within the dataset.Req
ESPARMCDTobacco Product ID Storage Conditions Element Short NameCharPARMCDTO

(ESPARMCD)

TopicShort name of the identifier or descriptor being described. Examples: "MANUFTEMP", "TRADENAM", HUMID"CIRCUMF".Req
ESPARMTobacco Product ID Element NameCharPARMTO(ESPARM)Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "ManufacturerTemperature", "Trade Name", "Circumference"Humidity".Req
ESVALTobacco Product ID Element ValueChar*
Result QualifierValue for the parameter in TOPARMCDESPARMCD/TOPARM for the product ESPARM for a condition within a set of conditions identified by SPTOBIDSTOCONID.Req
ESVALUTobacco 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
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.
ESVAL. Must be used when value for the parameter has units.Perm