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SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharTSIdentifierTwo-character abbreviation for the domain.Req
TSSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness within a parameter. Allows inclusion of multiple records for the same TSPARMCD.Req
TSGRPIDGroup IDChar
IdentifierUsed to tie together a group of related records.Perm
TSPARMCDTrial Summary Parameter Short NameChar(TSPARMCD)TopicTSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX".Req
TSPARMTrial Summary ParameterChar(TSPARM)Synonym QualifierTerm for the trial summary parameter. The value in TSPARM cannot be longer than 40 characters. Examples: "Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects".Req
TSVALParameter ValueChar*Result QualifierValue of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indication". TSVAL can only be null when TSVALNF is populated. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. See Assumption 8.Exp
TSVALNFParameter Value Null FlavorCharISO 21090 NullFlavorResult QualifierNull flavor for the value of TSPARM, to be populated only if TSVAL is null.Perm
TSVALCDParameter Value CodeChar

*

Result QualifierThis is the code of the term in TSVAL. For example, "6CW7F3G59X" is the code for gabapentin; "C49488" is the code for Y. The length of this variable can be longer than 8 to accommodate the length of the external terminology.Exp
TSVCDREFName of the Reference TerminologyChar

(DICTNAM)

Result QualifierThe name of the reference terminology from which TSVALCD is taken. For example; CDISC CT, SNOMED, ISO 8601.Exp
TSVCDVERVersion of the Reference TerminologyChar
Result QualifierThe version number of the reference terminology, if applicable.Exp

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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