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Comment: TOBA-544
Metadataspec
Notes;Core;Description
highlighttruekeys
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ClassFindings
DomainCV
Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharCVIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar
IdentifierIdentifier used to uniquely identify a subject across all studies for all application or submissions involving the product.Req
CVSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
CVGRPIDGroup IdentifierChar
IdentifierUsed to tie together a block of related records in a single domain for a subject and can be used to support relationships within the domain and between domains using RELREC. This is not the
treatment
dosing group number.Perm
CVSPID
Sponsor
Applicant-Defined IdentifierChar
Identifier
Sponsor
Applicant-defined reference identifier.Perm
CVTESTCDTest Short NameChar(SCVTSTCD)TopicShort name of the measurement, test, or examination described in CVTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in CVTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). CVTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: DIABP, HR, MAP, SYSBP.Req
CVTESTTest NameChar(SCVTST)Synonym QualifierLong name for CVTESTCD. The value in CVTEST cannot be longer than 40 characters. Examples: Diastolic Blood Pressure, Heart Rate, Mean Arterial Pressure, Systolic Blood Pressure.Req
CVPOSPosition of Subject During TestChar(POSITION)Record QualifierPosition of the subject during the measurement or examination. If the subject is restrained, populate with the position (example SITTING or STANDING); otherwise, populate with UNCONSTRAINED.Exp
CVORRESResult or Findings as CollectedChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
CVORRESUUnit of the Original ResultChar(UNIT)Variable QualifierThe unit for the original result. The unit of the original result should be mapped to a synonymous unit on the Controlled Terminology (http://www.cdisc.org/terminology) list.Exp
CVSTRESCStandardized Result in Character FormatChar
Result QualifierContains the result value for all findings, copied or derived from CVORRES in a standard format or standard units. CVSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in CVSTRESN.Exp
CVSTRESNStandardized Result in Numeric FormatNum
Result QualifierUsed for continuous or numeric results or findings in standard format; contains the numeric form of CVSTRESC. CVSTRESN should store all numeric test results or findings.Exp
CVSTRESUUnit of the Standardized ResultChar(UNIT)Variable QualifierStandardized unit used for CVSTRESC and CVSTRESN.Exp
CVSTATCompletion StatusChar(ND)Record QualifierUsed to indicate when a test is not done or result is missing. Should be null if a result exists in CVORRES.Perm
CVREASNDReason Not DoneChar
Record QualifierDescribes why CVSTAT is NOT DONE, such as BROKEN EQUIPMENT.Perm
CVMETHODMethod of TestChar
Record QualifierMethod of the test or examination. Examples: Intravascular, External Cuff.Exp
CVCSTATEConsciousness StateChar(CSTATE)Record QualifierConsciousness state of the subject at the time of measurement. Examples: CONSCIOUS, SEMI-CONSCIOUS, UNCONSCIOUS.Exp
CVBLFLBaseline FlagChar(NY)Record QualifierA baseline indicator may be used to calculate differences or changes from baseline. Value should be Y or null. The baseline flag is
sponsor
applicant defined.Exp
CVDRVFLDerived FlagChar(NY)Record QualifierUsed to indicate a derived record. The value should be Y or null.Perm
CVEXCLFLExclusion FlagChar(NY)Record QualifierY if the result should be excluded from all calculations, otherwise null.Perm
CVREASEXReason for ExclusionChar
Record QualifierThe reason the result should be excluded from all calculations. Used only when CVEXCLFL is Y.Perm
CVUSCHFLUnscheduled FlagChar(NY)Record QualifierIndicates whether the timing of the performed test or observation was unscheduled. If a test or observation was performed based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null.Perm
CVDTCDate/Time of Cardiovascular TestCharISO 8601 datetime or intervalTimingDate/Time of cardiovascular data collection, in ISO 8601 format. For measurements related to a continuous evaluation interval, CVDTC should be used to indicate the start date/time of that interval.Exp
CVENDTCEnd Date/Time of Cardiovascular TestCharISO 8601 datetime or intervalTimingDate/Time of end of a cardiovascular evaluation interval, in ISO 8601 format. Should be populated when CVDTC represents the start date/time of a continuous evaluation interval.Perm
CVDYStudy Day of Cardiovascular TestNum
TimingStudy day of cardiovascular data collection, in integer days. For measurements related to a continuous evaluation interval, CVDY can be used to indicate start day of that interval. The algorithm for calculating the day must be relative to the
sponsor
applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
CVENDYStudy Day of End of Cardiovascular TestNum
TimingStudy day of the end of a cardiovascular evaluation interval, in integer days. Can be populated when CVDY represents the start day of a continuous evaluation interval. The algorithm for calculating the day must be relative to the
sponsor
applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
CVNOMDYNominal Study Day for TabulationsNum
TimingNominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer.Exp
CVNOMLBLLabel for Nominal Study DayChar
TimingA label for a given value of CVNOMDY as presented in the study report Examples: Pretreatment, Week 4, Day 28.Perm
CVTPTPlanned Time Point NameChar
TimingText description of time when data should be collected. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See CVTPTNUM and CVTPTREF. Examples: Predose, 1 Hour Postdose.Exp
CVTPTNUMPlanned Time Point NumberNum
TimingNumerical version of CVTPT to aid in sorting.Exp
CVELTMPlanned Elapsed Time from Time Point RefCharISO 8601 durationTimingPlanned elapsed time (in ISO 8601 format) relative to a fixed time point reference (CVTPTREF). 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 CVTPTREF, or "PT8H" to represent the period of 8 hours after the reference point indicated by CVTPTREF.Exp
CVTPTREFTime Point ReferenceChar
TimingName of the fixed reference point referred to by CVELTM, if used for CVTPTNUM, and CVTPT. It is recommended that CVTPTREF be as descriptive as possible so the reference time point can be inferred without looking at others variables. Example: DAY 1 FIRST DOSE.Exp
CVRFTDTCDate/Time of Reference Time PointCharISO 8601 datetime or intervalTimingDate/Time of the reference time point, CVTPTREF.Perm
CVEVLINTEvaluation IntervalCharISO 8601 duration or intervalTimingLength of evaluation interval in ISO 8601 duration format. Used in place of CVSTINT and CVENINT when CVTPTREF is not available.Perm
CVSTINTPlanned Start of Assessment IntervalCharISO 8601 durationTimingPlanned start of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT1H.Exp
CVENINTPlanned End of Assessment IntervalCharISO 8601 durationTimingPlanned end of an assessment interval relative to Time Point Reference (CVTPTREF) in ISO 8601 duration format. Example: When the evaluation interval is from 1 to 2 hours after dosing, the value would be PT2H.Exp