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Jira
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serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-445

Metadataspec
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Shareqc_sdtm4tig10_ds
ClassStudy Reference
DomainES
Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC 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 AbbreviationCharESIdentifierTwo-character abbreviation for the domain.Req
STOCONIDApplicant-defined Storage Conditions IDChar
IdentifierApplicant-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 Conditions"). It must be unique for each unique set of storage conditions as defined by the specific values of ESPARMCD-ESVAL pairs.Req
ESSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter within the set of storage conditions represent by STOCONID within the dataset.Req
ESPARMCDStorage Conditions Element Short NameCharPARMCDES

(ESPARMCD)

TopicShort name of the identifier or descriptor being described. Examples: "TEMP", "HUMID".Req
ESPARMTobacco Product ID Element NameCharPARMES(ESPARM)Synonym QualifierName of the identifying parameter or descriptor being described. Examples: "Temperature", "Humidity".Req
ESVALTobacco Product ID Element ValueChar
Result QualifierValue for the parameter in ESPARMCD/ESPARM for a condition within a set of conditions identified by STOCONID.Req
ESVALUTobacco Product ID Element Value UnitChar(UNIT)Result QualifierUnit for the value in ESVAL. Must be used when value for the parameter has units.Perm