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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.

Perm