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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
SE
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
SESEQ
Sequence Number
Num
Identifier
Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number.
Req
ETCD
Element Code
Char
Topic
ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions.
Req
ELEMENT
Description of Element
Char
Synonym Qualifier
The name of the Element..
Perm
SESTDTC
Start Date/Time of Element
Char
ISO 8601
Timing
Start date/time for an Element for each subject, in ISO 8601 format.
Req
SEENDTC
End Date/Time of Element
Char
ISO 8601
Timing
End date/time for an Element for each subject, in ISO 8601 format.
Exp
SEUPDES
Description of Unplanned Element
Char
Synonym Qualifier
Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN.