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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study.
Req
DOMAIN
Domain Abbreviation
Char
DS
Identifier
Two-character abbreviation for the domain.
Req
USUBJID
Unique Subject Identifier
Char
Identifier
Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
Req
DSSEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
Req
DSTERM
Reported Term for the Disposition Event
Char
Topic
DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD.
Indicates 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
VISITDY
Planned Study Day of Disposition
Num
Timing
Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity.
Perm
DSSTDTC
Date/Time of Disposition
Char
ISO 8601
Timing
Date/Time of the disposition event, in ISO 8601 format.
Req
DSSTDY
Study Day of Disposition
Num
Timing
Study 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
DSNOMDY
Nominal Study Day for Tabulations
Num
Timing
Nominal 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
DSNOMLBL
Label for Nominal Study Day
Char
Timing
A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac.