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

Metadata check macro is applied and detected issue(s). Please address finding(s) listed below the specification table. An FAQ is available to aid troubleshooting. Release Notes

Variable NameVariable LabelTypeControlled Terms, Codelist or Format1RoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharREIdentifierTwo-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
SPDEVIDApplicant Device IdentifierChar
IdentifierApplicant-defined identifier for a device.Perm
RESEQSequence NumberNum
IdentifierSequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number (including decimals) and does not have to start at 1.Req
REGRPIDGroup IDChar
IdentifierOptional group identifier, used to link together a block of related records within a subject in a domain.Perm
REREFIDReference IDChar
IdentifierOptional internal or external procedure identifier.
Perm
RESPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined identifier. Perhaps preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database.Perm
RELNKIDLink IDChar
IdentifierIdentifier used to link related records across domains. This may be a one-to-one or a one-to-many relationship.Perm
RELNKGRPLink GroupChar
IdentifierIdentifier used to link related records across domains. This will usually be a many-to-one relationship.Perm
RETESTCDShort Name of Respiratory TestChar(RETESTCD)TopicShort name of the measurement, test, or examination. It can be used as a column name when converting a dataset from a vertical format to a horizontal format. The value in RETESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). RETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "FEV1", "FVC".Req
RETESTName of Respiratory TestChar(RETEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. The value in RETEST cannot be longer than 40 characters. Examples: "Forced Expiratory Volume in 1 Second", "Forced Vital Capacity".Req
RECATCategory for Respiratory TestChar
Grouping QualifierUsed to categorize observations across subjects.Perm
RESCATSubcategory for Respiratory TestChar
Grouping QualifierA further categorization.Perm
REPOSPosition of Subject During ObservationChar(POSITION)Record QualifierPosition of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".Perm
REORRESResult or Finding in Original UnitsChar
Result QualifierResult of the procedure measurement or finding as originally received or collected.Exp
REORRESUOriginal UnitsChar(UNIT)Variable QualifierOriginal units in which the data were collected. The unit for REORRES and REORREF.Perm
REORREFReference Result in Original UnitsChar
Variable QualifierReference result for continuous measurements in original units. Should be collected only for continuous results.Perm
RESTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains the result value for all findings, copied or derived from REORRES in a standard format or in standard units. RESTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RESTRESN.Exp
RESTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from RESTRESC. RESTRESN should store all numeric test results or findings.Perm
RESTRESUStandard UnitsChar(UNIT)Variable QualifierStandardized unit used for RESTRESC, RESTRESN and RESTREFN.Perm
RESTREFCCharacter Reference ResultChar
Variable QualifierReference value for the result or finding copied or derived from --ORREF in a standard format.Perm
RESTREFNNumeric Reference Result in Std UnitsNum
Variable QualifierReference result for continuous measurements in standard units. Should be populated only for continuous results.Perm
RESTATCompletion StatusChar(ND)Record QualifierUsed to indicate that a test was not done or a measurement was not taken. Should be null if a result exists in REORRES.Perm
REREASNDReason Not DoneChar
Record QualifierDescribes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with RESTAT when value is "NOT DONE".Perm
RELOCLocation Used for the MeasurementChar(LOC)Record QualifierAnatomical location of the subject relevant to the collection of the measurement. Examples: "LUNG", "BRONCHUS".Perm
RELATLateralityChar(LAT)Variable QualifierSide of the body used to collect measurement. Examples: "RIGHT", "LEFT".Perm
REDIRDirectionalityChar(DIR)Variable QualifierQualifier for anatomical location or specimen further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL".Perm
REMETHODMethod of Test or ExaminationChar(METHOD)Record QualifierMethod used to create the result.Perm
RELOBXFLLast 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
REEVALEvaluatorChar(EVAL)Record QualifierRole of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Examples: "ADJUDICATION COMMITTEE", "INDEPENDENT ASSESSOR", "RADIOLOGIST".Perm
REEVALIDEvaluator IdentifierChar(MEDEVAL)Variable QualifierUsed to distinguish multiple evaluators with the same role recorded in REEVAL. Examples: "RADIOLOGIST1" or "RADIOLOGIST2".Perm
REREPNUMRepetition NumberNum
Record QualifierThe instance number of a test that is repeated within a given time frame for the same test. The level of granularity can vary, e.g., within a time point or within a visit. For example, multiple measurements of pulmonary function.Perm
VISITNUMVisit NumberNum
TimingClinical encounter number. Numeric version of VISIT, used for sorting.Exp
VISITVisit NameChar
TimingProtocol-defined description of a clinical encounter. 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 for the Element in which the assessment was made.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the date/time at which the assessment was made.Perm
REDTCDate/Time of CollectionCharISO 8601 datetime or intervalTimingDate/time of procedure or test.Exp
REDYStudy Day of Visit/Collection/ExamNum
TimingActual study day of visit/collection/exam expressed in integer days relative to the applicant-defined RFSTDTC in Demographics.Perm
RETPTPlanned Time Point NameChar
TimingText description of time when a measurement or observation should be taken as defined in the protocol. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See RETPTNUM and RETPTREF. Examples: "Start", "5 minutes post".Perm
RETPTNUMPlanned Time Point NumberNum
TimingNumeric version of RETPT to aid in sorting.Perm
REELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned Elapsed time relative to a planned fixed reference (RETPTREF). Not a clock time or a date/time variable, but an interval, represented as ISO duration. Examples: "-PT15M" to represent 15 minutes prior to the reference time point indicated by RETPTREF, or "PT8H" to represent 8 hours after the reference time point represented by RETPTREF.Perm
RETPTREFTime Point ReferenceChar
TimingDescription of the fixed reference point referred to by REELTM, RETPTNUM, and RETPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".Perm
RERFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/time for a fixed reference time point defined by RETPTREF.Perm

Metadata Checks Findings

Metadata Check User Macros FAQ
  • Structure: Mismatch column 4 label: Controlled Terms, Codelist or Format1 (seen) vs. Controlled Terms, Codelist, or Format (expected)
  • Notice: <strong>Checks for table content are suspended due to structrual issues reported above. Content checks will resume after all structural issues are resolved</strong>
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