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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
TX
Identifier
Two-character abbreviation for the domain.
Req
SETCD
Set Code
Char
Identifier
Short name of the Trial Set. The same element may occur more than once within an Arm. Maximum 8 characters. This represents the Trial Set for which parameters are being submitted.
Req
SET
Set Description
Char
Synonym Qualifier
Long description of a specific Trial Set, as defined by the applicant.
Req
TXSEQ
Sequence Number
Num
Identifier
Unique number for this record within this dataset (This sequence should be unique within the entire dataset because there is no USUBJID.).
Term for the Trial Set parameter. Maximum 40 characters.
Req
TXVAL
Trial Set Parameter Value
Char
Result Qualifier
Value of the Trial Set parameter (e.g., Fed ad libitum or Restricted Feeding when TXPARM is FEEDREG). Some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.4.2 that lists all defined Trial Set parameters.