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