Description

An events domain that contains information encompassing and representing data related to subject disposition.

ds.xpt, Disposition — Events. One record per subject, Tabulation.


Specification

TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

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 AbbreviationCharDSIdentifierTwo-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
DSSEQSequence NumberNum
IdentifierSequence number given to ensure uniqueness of subject records within a domain. May be any valid number.Req
DSTERMReported Term for the Disposition EventChar
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
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
TimingStudy day of the disposition event, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain.Perm
DSNOMDYNominal 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
DSNOMLBLLabel for Nominal Study DayChar
TimingA label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.Perm


Assumptions

  1. Definition: The Disposition (DS) dataset provides a record of the final disposition of subjects, which can be recorded at any stage throughout a study. At study completion, a record must exist for each subject in the study.
  2. DS Description and coding: DSTERM is not under controlled terminology, but should be mapped to controlled terminology for DSDECOD.
  3. DSSTDTC is used for the date/time of the disposition event. Disposition events do not have end dates, because these events do not span an interval but occur at a single date/time (e.g., date of terminal sacrifice). An interval of uncertainty cannot be used for DSSTDTC.

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