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Comment: removed a non-printing character causing metadata check to flag variable
Metadataspec
highlighttrue
keysDescription;Notes;Core
Shareqc_sdtm4tig10_ds
ClassFindings
DomainLB
Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharLBIdentifierTwo-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
LBSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
LBGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
LBREFIDSpecimen IDChar
IdentifierInternal or external specimen identifier. Example: Specimen ID.Perm
LBSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database. Example: Line number on the Lab page.Perm
LBTESTCDLab Test or Examination Short Name.Char(LBTESTCD)TopicShort name of the measurement, test, or examination described in LBTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in LBTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). LBTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "ALT", "LDH".Req
LBTESTLab Test or Examination NameChar(LBTEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. Note any test normally performed by a clinical laboratory is considered a lab test. The value in LBTEST cannot be longer than 40 characters. Examples: "Alanine Aminotransferase", "Lactate Dehydrogenase".Req
LBCATCategory for Lab TestChar*
Grouping QualifierUsed to define a category of related records across subjects. Examples: "HEMATOLOGY", "URINALYSIS", "CHEMISTRY".Exp
LBSCATSubcategory for Lab TestChar*
Grouping QualifierA further categorization of a test category such as "DIFFERENTIAL", "COAGULATION", "LIVER FUNCTION", "ELECTROLYTES".Perm
LBORRESResult or Finding in Original UnitsChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
LBORRESUOriginal UnitsChar(UNIT)Variable QualifierOriginal units in which the data were collected. The unit for LBORRES. Example: "g/L".Exp
LBORNRLOReference Range Lower Limit in Orig UnitChar
Variable QualifierLower end of reference range for continuous measurement in original units. Should be populated only for continuous results.Exp
LBORNRHIReference Range Upper Limit in Orig UnitChar
Variable QualifierUpper end of reference range for continuous measurement in original units. Should be populated only for continuous results.Exp
LBSTRESCCharacter Result/Finding in Std FormatChar(LBSTRESC)Result Qualifier

Contains the result value for all findings, copied or derived from LBORRES in a standard format or standard units. LBSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in LBSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in LBORRES and these results effectively have the same meaning, they could be represented in standard format in LBSTRESC as "NEGATIVE". For other examples, see general assumptions.

Exp
LBSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from LBSTRESC. LBSTRESN should store all numeric test results or findings.Exp
LBSTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized unit used for LBSTRESC or LBSTRESN.Exp
LBSTNRLOReference Range Lower Limit-Std UnitsNum
Variable QualifierLower end of reference range for continuous measurements for LBSTRESC/LBSTRESN in standardized units. Should be populated only for continuous results.Exp
LBSTNRHIReference Range Upper Limit-Std UnitsNum
Variable QualifierUpper end of reference range for continuous measurements in standardized units. Should be populated only for continuous results.Exp
LBSTNRCReference Range for Char Rslt-Std UnitsChar
Variable QualifierFor normal range values that are character in ordinal scale or if categorical ranges were supplied (e.g., "-1 to +1", "NEGATIVE TO TRACE").Perm
LBSTREFCReference Result in Standard FormatChar
Variable QualifierReference value for the result or finding copied or derived from LBORREF in a standard format.Exp
LBNRINDReference Range IndicatorChar(NRIND)Variable Qualifier
  1. Indicates where the value falls with respect to reference range defined by LBORNRLO and LBORNRHI, LBSTNRLO and LBSTNRHI, or by LBSTNRC. Examples: "NORMAL", "ABNORMAL", "HIGH", "LOW".
  2. Should not be used to indicate clinical significance.
Exp
LBSTATCompletion StatusChar(ND)Record QualifierUsed to indicate exam not done. Should be null if a result exists in LBORRES.Perm
LBREASNDReason Test Not DoneChar
Record QualifierDescribes why a measurement or test was not performed, e.g., "BROKEN EQUIPMENT", "SUBJECT REFUSED", or "SPECIMEN LOST". Used in conjunction with LBSTAT when value is "NOT DONE".Perm
LBNAMVendor NameChar
Record QualifierThe name or identifier of the laboratory that performed the test.Perm
LBLOINCLOINC CodeChar
Synonym Qualifier
  1. Code for the lab test from the LOINC code system.
Perm
LBSPECSpecimen TypeChar(SPECTYPE)Record QualifierDefines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE", "DNA", "RNA".Perm
LBSPCCNDSpecimen ConditionChar(SPECCOND)Record QualifierFree or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC".Perm
LBMETHODMethod of Test or ExaminationChar(METHOD)Record QualifierMethod of the test or examination. Examples: "EIA" (Enzyme Immunoassay), "ELECTROPHORESIS", "DIPSTICK".Perm
LBLOBXFLLast Observation Before Exposure FlagChar(NY)Record QualifierOperationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. The value should be "Y" or null.Exp
LBFASTFasting StatusChar(NY)Record QualifierIndicator used to identify fasting status such as "Y", "N", "U", or null if not relevant.Perm
LBTOXToxicityChar
Variable QualifierDescription of toxicity quantified by LBTOXGR.Perm
LBTOXGRStandard Toxicity GradeChar
Record QualifierRecords toxicity grade value using a standard toxicity scale (such as the NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2" and not "Grade 2").Perm
LBLLOQLower Limit of QuantitationNum
Variable QualifierThe lowest threshold for reliably quantifying the amount of substance measured by a specific test, in standardized units.Perm
LBULOQUpper Limit of QuantitationNum
Variable QualifierThe highest threshold for reliably detecting the result of a specific test in standardized units.Perm
VISITNUMVisit NumberNum
Timing
  1. Clinical encounter numberAn assigned numeric identifier that aligns to the chronological order of an encounter.
  2. Numeric version of VISIT, used for sorting.
Exp
VISITVisit NameChar
Timing
  1. ProtocolThe label for a protocol-defined description of clinical encounter.
  2. May be used in addition to VISITNUM and/or VISITDY.
Perm
VISITDYPlanned Study Day of VisitNum
TimingPlanned study day of the visit based upon RFSTDTC in Demographics.Perm
TAETORDPlanned Order of Element within ArmNum
TimingNumber that gives the planned order of the Element within the Arm.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time of the observation, or the date/time of collection if start date/time is not collected.Perm
LBDTCDate/Time of Specimen CollectionCharISO 8601 datetime or intervalTimingDate/time of specimen collection represented in ISO 8601 character format.Exp
LBENDTCEnd Date/Time of Specimen CollectionCharISO 8601 datetime or intervalTimingEnd date/time of specimen collection represented in ISO 8601 character format.Perm
LBDYStudy Day of Specimen CollectionNum
Timing
  1. Study day of specimen collection, measured as integer days.
  2. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission.
Perm
LBENDYStudy Day of End of ObservationNum
TimingActual study day of end of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics.Perm
LBTPTPlanned Time Point NameChar
Timing
  1. Text description of time when specimen should be taken.
  2. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See LBTPTNUM and LBTPTREF. Examples: "Start", "5 min post".
Perm
LBTPTNUMPlanned Time Point NumberNum
TimingNumerical version of LBTPT to aid in sorting.Perm
LBELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time (in ISO 8601) relative to a planned fixed reference (LBTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date/time variable. Represented as ISO 8601 duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by LBTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by LBTPTREF.Perm
LBTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by LBELTM, LBTPTNUM, and LBTPT.Perm
LBRFTDTCDate/Time of Reference Time Point
Char
Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keySDTM-754
ISO 8601 datetime or intervalTimingDate/time of the reference time point, LBTPTREF.Perm