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Metadataspec
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keysNotes;Core;Description
Variable NameVariable LabelTypeControlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar
IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharBWIdentifierTwo-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
BWSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
BWTESTCDTest Short NameChar(BWTESTCD)TopicShort name of the measurement, test, or examination described in BWTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in BWTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST" is not valid). BWTESTCD cannot contain characters other than letters, numbers, or underscores.Req
BWTESTTest NameChar(BWTEST)Synonym QualifierLong name for BWTESTCD. The value in BWTEST cannot be longer than 40 characters.Req
BWORRESResult or Findings as CollectedChar
Result QualifierResult of the measurement or finding as originally received or collected.Exp
BWORRESUUnit 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 list.Exp
BWSTRESCStandardized Result in Character FormatChar
Result QualifierContains the result value for all findings, copied or derived from BWORRES in a standard format or standard units. BWSTRESC should store all results or findings in character format; if results are numeric, they should also be submitted in numeric format in BWSTRESN.Exp
BWSTRESNStandardized Result in Numeric FormatNum
Result QualifierUsed for numeric results or findings in standard format; contains the numeric form of BWSTRESC. BWSTRESN should store all numeric test results or findings.Exp
BWSTRESUUnit of the Standardized ResultChar(UNIT)Variable QualifierStandardized unit used for BWSTRESC and BWSTRESN.Exp
BWSTATCompletion StatusChar(ND)Record QualifierUsed to indicate when a test is not done or result is missing. Should be null if a result exists in BWORRES.Perm
BWREASNDReason Not DoneChar
Record QualifierDescribes why BWSTAT is NOT DONE, such as BROKEN EQUIPMENT or TECHNICIAN OVERSIGHT.Perm
BWBLFLBaseline 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 defined.Exp
BWFASTFasting StatusChar(NY)Record QualifierIndicator used to identify fasting status. The value should by Y or null.Perm
BWEXCLFLExclusion FlagChar(NY)Record QualifierY if the result should be excluded from all calculations, otherwise null.Perm
BWREASEXReason for ExclusionChar
Record QualifierThe reason the result should be excluded from all calculations. Used only when BWEXCLFL is Y.Perm
BWUSCHFLUnscheduled FlagChar(NY)Record QualifierIndicates whether the timing of a 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
VISITDYPlanned Study Day of CollectionNum
TimingPlanned study day of collection. Should be an integer.Perm
BWDTCDate/Time Animal WeighedCharISO 8601TimingDate/Time of body weight collection in ISO 8601 format.Exp
BWDYStudy Day Animal WeighedNum
TimingStudy day of body weight collection, in integer days. The algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in the Demographics (DM) domain.Perm
BWNOMDYNominal 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
BWNOMLBLLabel for Nominal Study DayChar
TimingA label for a given value of BWNOMDY as presented in the study report. Examples: "Week 4," "Day 28," "Terminal Sac".Perm