You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 10 Current »

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 AbbreviationCharVSIdentifierTwo-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
VSSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
VSGRPIDGroup IDChar
IdentifierUsed to tie together a block of related records in a single domain for a subject.Perm
VSSPIDApplicant-Defined IdentifierChar
IdentifierApplicant-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the applicant's operational database.Perm
VSTESTCDVital Signs Test Short NameChar(VSTESTCD)TopicShort name of the measurement, test, or examination described in VSTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in VSTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). VSTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "SYSBP", "DIABP", "BMI".Req
VSTESTVital Signs Test NameChar(VSTEST)Synonym QualifierVerbatim name of the test or examination used to obtain the measurement or finding. The value in VSTEST cannot be longer than 40 characters. Examples: "Systolic Blood Pressure", "Diastolic Blood Pressure", "Body Mass Index".Req
VSCATCategory for Vital SignsChar
Grouping QualifierUsed to define a category of related records.Perm
VSSCATSubcategory for Vital SignsChar
Grouping QualifierA further categorization of a measurement or examination.Perm
VSPOSVital Signs Position of SubjectChar(POSITION)Record QualifierPosition of the subject during a measurement or examination. Examples: "SUPINE", "STANDING", "SITTING".Perm
VSORRESResult or Finding in Original UnitsChar
Result QualifierResult of the vital signs measurement as originally received or collected.Exp
VSORRESUOriginal UnitsChar(VSRESU)Variable QualifierOriginal units in which the data were collected. The unit for VSORRES. Examples: "in", "LB", "beats/min".Exp
VSSTRESCCharacter Result/Finding in Std FormatChar
Result QualifierContains the result value for all findings, copied or derived from VSORRES in a standard format or standard units. VSSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in VSSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in VSORRES, and these results effectively have the same meaning, they could be represented in standard format in VSSTRESC as "NEGATIVE".Exp
VSSTRESNNumeric Result/Finding in Standard UnitsNum
Result QualifierUsed for continuous or numeric results or findings in standard format; copied in numeric format from VSSTRESC. VSSTRESN should store all numeric test results or findings.Exp
VSSTRESUStandard UnitsChar(VSRESU)Variable QualifierStandardized unit used for VSSTRESC and VSSTRESN.Exp
VSSTATCompletion StatusChar(ND)Record QualifierUsed to indicate that a vital sign measurement was not done. Should be null if a result exists in VSORRES.Perm
VSREASNDReason Not PerformedChar
Record QualifierDescribes why a measurement or test was not performed. Examples: "BROKEN EQUIPMENT", "SUBJECT REFUSED". Used in conjunction with VSSTAT when value is "NOT DONE".Perm
VSLOCLocation of Vital Signs MeasurementChar(LOC)Record QualifierLocation relevant to the collection of vital signs measurement. Example: "ARM" for blood pressure.Perm
VSLATLateralityChar(LAT)Result QualifierQualifier for anatomical location or specimen further detailing laterality. Examples: "RIGHT", "LEFT", "BILATERAL".Perm
VSLOBXFLLast Observation Before Exposure FlagChar(NY)Record QualifierOperationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null.Exp
VSTOXToxicityChar
Variable QualifierDescription of toxicity quantified by VSTOXGR.Perm
VSTOXGRStandard Toxicity GradeChar
Record QualifierRecords toxicity grade value using a standard toxicity scale (e.g., NCI CTCAE). If value is from a numeric scale, represent only the number (e.g., "2", not "Grade 2").Perm

VSCLSIG

Clinically Significant, CollectedChar(NY)Record QualifierUsed to indicate whether a collected observation is clinically significant based on judgment.Perm
VISITNUMVisit NumberNum
Timing
  1. An assigned numeric identifier that aligns to the chronological order of an encounter.
  2. Numeric version of VISIT, used for sorting.
Exp
VISITVisit NameChar
TimingProtocol-defined description of 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.Perm
EPOCHEpochChar(EPOCH)TimingEpoch associated with the start date/time at which the assessment was made.Perm
VSDTCDate/Time of MeasurementsCharISO 8601 datetime or intervalTimingDate and time of the vital signs assessment represented in ISO 8601 character format.Exp
VSDYStudy Day of Vital SignsNum
TimingStudy day of vital signs measurements, measured as integer days. Algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in Demographics.Perm
VSTPTPlanned Time Point NameChar
TimingText description of time when measurement should be taken. This may be represented as an elapsed time relative to a fixed reference point (e.g., time of last dose). See VSTPTNUM and VSTPTREF. Examples: "START", "5 MIN POST".Perm
VSTPTNUMPlanned Time Point NumberNum
TimingNumerical version of VSTPT to aid in sorting.Perm
VSELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time (in ISO 8601) relative to a planned fixed reference (VSTPTREF). This variable is useful where there are repetitive measures. Not a clock time or a date time variable. Represented as an ISO 8601 Duration. Examples: "-PT15M" to represent the period of 15 minutes prior to the reference point indicated by VSTPTREF, "PT8H" to represent the period of 8 hours after the reference point indicated by VSTPTREF.Perm
VSTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by VSELTM, VSTPTNUM, and VSTPT. Examples: "PREVIOUS DOSE", "PREVIOUS MEAL".Perm
VSRFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/time of the reference time point, VSTPTREF.Perm
  • No labels