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Metadataspec
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Shareqc_send4tig10_ds
ClassEvents
DomainDS
Variable NameVariable LabelType

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Controlled Terms, Codelist, or FormatRoleCDISC NotesCore
STUDYIDStudy IdentifierChar

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IdentifierUnique identifier for a study.Req
DOMAINDomain AbbreviationCharDSIdentifierTwo-character abbreviation for the domain.Req
USUBJIDUnique Subject IdentifierChar

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IdentifierIdentifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.Req
DSSEQSequence NumberNum

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IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DSTERMReported Term for the Disposition EventChar

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TopicDSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD.Req
DSDECODStandardized Disposition TermChar(DSDECOD)Synonym QualifierContains the result in a standard format.Req
DSUSCHFLUnscheduled FlagChar(NY)Record QualifierIndicates whether the subject's disposition was unscheduled. If the subject's disposition was based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null.Exp
VISITDYPlanned Study Day of DispositionNum

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TimingPlanned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity.Perm
DSSTDTCDate/Time of DispositionCharISO 8601 datetime or intervalTimingDate/Time of the disposition event, in ISO 8601 format.Req
DSSTDYStudy Day of DispositionNum

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TimingStudy day of the disposition event, in integer days. The algorithm for calculations must be relative to the

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applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
DSNOMDYNominal Study Day for TabulationsNum

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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
DSNOMLBLLabel for Nominal Study DayChar

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TimingA label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.Perm