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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 AbbreviationCharPCIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierUnique subject identifier within the submission.Req
PCSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
PCGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain to support relationships within the domain and between domains.Perm
PCREFIDReference IDChar
IdentifierInternal or external specimen identifier.Perm
PCSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number.Perm
PCTESTCDPharmacokinetic Test Short NameChar
TopicShort name of the analyte or specimen characteristic. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in PCTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). PCTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "ASA", "VOL", "SPG".Req
PCTESTPharmacokinetic Test NameChar
Synonym QualifierName of the analyte or specimen characteristic. Note any test normally performed by a clinical laboratory is considered a lab test. The value in PCTEST cannot be longer than 40 characters. Examples: "Acetylsalicylic Acid", "Volume", "Specific Gravity".Req
PCCATTest CategoryChar
Grouping QualifierUsed to define a category of related records. Examples: "ANALYTE", "SPECIMEN PROPERTY".Perm
PCSCATTest SubcategoryChar
Grouping QualifierA further categorization of a test category.Perm
PCORRESResult or Finding in Original UnitsChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
PCORRESUOriginal UnitsChar(PKUNIT)Variable QualifierOriginal units in which the data were collected. The unit for PCORRES. Example: "mg/L".Exp
PCSTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains the result value for all findings, copied or derived from PCORRES in a standard format or standard units. PCSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in PCSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in PCORRES, and these results effectively have the same meaning, they could be represented in standard format in PCSTRESC as "NEGATIVE". For other examples, see general assumptions.Exp
PCSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from PCSTRESC. PCSTRESN should store all numeric test results or findings.Exp
PCSTRESUStandard UnitsChar(PKUNIT)Variable QualifierStandardized unit used for PCSTRESC and PCSTRESN.Exp
PCSTATCompletion StatusChar(ND)Record QualifierUsed to indicate a result was not obtained. Should be null if a result exists in PCORRES.Perm
PCREASNDReason Test Not DoneChar
Record QualifierDescribes why a result was not obtained, such as "SPECIMEN LOST". Used in conjunction with PCSTAT when value is "NOT DONE".Perm
PCNAMVendor NameChar
Record QualifierName or identifier of the laboratory or vendor who provides the test results.Exp
PCSPECSpecimen Material TypeChar(SPECTYPE)Record QualifierDefines the type of specimen used for a measurement. Examples: "SERUM", "PLASMA", "URINE".Exp
PCSPCCNDSpecimen ConditionChar(SPECCOND)Record QualifierFree or standardized text describing the condition of the specimen, e.g., "HEMOLYZED", "ICTERIC", "LIPEMIC".Perm
PCMETHODMethod of Test or ExaminationChar(METHOD)Record QualifierMethod of the test or examination. Examples: "HPLC/MS", "ELISA". This should contain sufficient information and granularity to allow differentiation of various methods that might have been used within a study.Perm
PCFASTFasting StatusChar(NY)Record QualifierIndicator used to identify fasting status.Perm
PCLLOQLower Limit of QuantitationNum
Variable QualifierIndicates the lower limit of quantitation for an assay. Units should be those used in PCSTRESU.Exp
PCULOQUpper Limit of QuantitationNum
Variable QualifierIndicates the upper limit of quantitation for an assay. Units should be those used in PCSTRESU.Perm
VISITNUMVisit NumberNum
Timing
  1. Clinical encounter number.
  2. Numeric version of VISIT, used for sorting.
Exp
VISITVisit NameChar
Timing
  1. 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
PCDTCDate/Time of Specimen CollectionCharISO 8601 datetime or intervalTimingDate/time of specimen collection represented in ISO 8601 character format. If there is no end time, then this will be the collection time.Exp
PCENDTCEnd Date/Time of Specimen CollectionCharISO 8601 datetime or intervalTimingEnd date/time of specimen collection represented in ISO 8601 character format. If there is no end time, the collection time should be stored in PCDTC, and PCENDTC should be null.Perm
PCDYActual Study 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.
Perm
PCENDYStudy 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
PCTPTPlanned 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 exposure. See PCTPTNUM and PCTPTREF. Examples: "Start", "5 min post".
Perm
PCTPTNUMPlanned Time Point NumberNum
TimingNumerical version of PCTPT to aid in sorting.Perm
PCELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time (in ISO 8601) relative to a planned fixed reference (PCTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable.Perm
PCTPTREFTime Point ReferenceChar
TimingName of the fixed reference point used as a basis for PCTPT, PCTPTNUM, and PCELTM. Example: "Most Recent Dose".Perm
PCRFTDTCDate/Time of Reference PointCharISO 8601 datetime or intervalTimingDate/time of the reference time point described by PCTPTREF.Perm
PCEVLINTEvaluation IntervalCharISO 8601 datetime or intervalTimingEvaluation Interval associated with a PCTEST record represented in ISO 8601 character format. Example: "-PT2H" to represent an interval of 2 hours prior to a PCTPT.Perm
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