SEND TX specification

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 sponsor.

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.)

Req

TXPARMCD

Trial Set Parameter Short Name

Char

(STSPRMCD)

Topic

Short character value for the Trial Set parameter described in TXPARM. Maximum 8 characters.

Req

TXPARM

Trial Set Parameter

Char

(STSPRM)

Synonym Qualifier

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.

Req