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TIG v1.0 Metadata Check for SDTM Domain Specification Table Beta 3.2

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 FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharEXIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
EXSEQSequence NumberNum
IdentifierSequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
EXGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
EXREFIDReference IDChar
IdentifierInternal or external identifier.Perm
EXSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on a CRF Page.Perm
EXLNKIDLink IDChar
IdentifierIdentifier used to link related records across domains.Perm
EXLNKGRPLink Group IDChar
IdentifierIdentifier used to link related, grouped records across domains.Perm
EXTRTName of ProductChar
TopicName of the protocol-specified study product given during the dosing period for the observation.Req
EXCATCategory of ProductChar
Grouping QualifierUsed to define a category of EXTRT values.Perm
EXSCATSubcategory of ProductChar
Grouping QualifierA further categorization of EXCAT values.Perm
EXDOSEDoseNum
Record QualifierAmount of EXTRT when numeric. Not populated when EXDOSTXT is populated.Exp
EXDOSTXTDose DescriptionChar
Record QualifierAmount of EXTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: 200-400. Not populated when EXDOSE is populated.Perm
EXDOSUDose UnitsChar(UNIT)Variable QualifierUnits for EXDOSE, EXDOSTOT, or EXDOSTXT representing protocol-specified values. Examples: "ng", "mg", "mg/kg", "mg/m2".Exp
EXDOSFRMDose FormChar(FRM)Variable QualifierDose form for EXTRT.Exp
EXDOSFRQDosing Frequency per IntervalChar(FREQ)Variable QualifierUsually expressed as the number of repeated administrations of EXDOSE within a specific time period.Perm
EXDOSRGMIntended Dose RegimenChar
Variable QualifierText description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON, TWO WEEKS OFF".Perm
EXROUTERoute of AdministrationChar(ROUTE)Variable QualifierRoute of administration for the intervention. Examples: "ORAL".Perm
EXLOTLot NumberChar
Record QualifierLot number of the intervention product.Perm
EXLOCLocation of Dose AdministrationChar(LOC)Record QualifierSpecifies location of administration. Examples: "ARM", "LIP".Perm
EXLATLateralityChar(LAT)Variable QualifierQualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT".Perm
EXDIRDirectionalityChar(DIR)Variable QualifierQualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER".Perm
EXFASTFasting StatusChar(NY)Record QualifierIndicator used to identify fasting status. Examples: "Y", "N".Perm
EXADJReason for Dose AdjustmentChar
Record QualifierDescribes reason or explanation of why a dose is adjusted.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the Element within the Arm.Perm
EPOCHEpochChar(EPOCH)TimingTrial Epoch of the Exposure record. Examples: "RUN-IN", "FOLLOW-UP".Perm
EXSTDTCStart Date/Time of ExposureCharISO 8601 datetime or intervalTimingThe date/time when administration of the product indicated by EXTRT and EXDOSE began.Exp
EXENDTCEnd Date/Time of ExposureCharISO 8601 datetime or intervalTimingThe date/time when administration of the product indicated by EXTRT and EXDOSE ended. For administrations considered given at a point in time, where only an administration date/time is collected, EXSTDTC should be copied to EXENDTC as the standard representation.Exp
EXSTDYStudy Day of Start of ExposureNum
TimingStudy day of EXSTDTC relative to DM.RFSTDTC.Perm
EXENDYStudy Day of End of ExposureNum
TimingStudy day of EXENDTC relative to DM.RFSTDTC.Perm
EXDURDuration of ExposureCharISO 8601 durationTimingCollected duration of administration. Used only if collected on the CRF and not derived from start and end date/times.Perm
EXTPTPlanned Time Point NameChar
Timing
  1. Text Description of time when administration should occur.
  2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See EXTPTNUM and EXTPTREF.
Perm
EXTPTNUMPlanned Time Point NumberNum
TimingNumerical version of EXTPT to aid in sorting.Perm
EXELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time relative to the planned fixed reference (EXTPTREF). This variable is useful where there are repetitive measures. Not a clock time.Perm
EXTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by EXELTM, EXTPTNUM, and EXTPT. Examples: PREVIOUS DOSE.Perm
EXRFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/time for a fixed reference time point defined by EXTPTREF.Perm
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