TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. 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

TA

Identifier

Two-character abbreviation for the domain.

Req

ARMCD

Planned Arm Code

Char


Topic

Short name of a specific ARM (may be up to 20 characters) used for sorting and programming. Should be populated in Demographics when Arms have been defined in this domain.

Req

ARM

Description of Planned Arm

Char


Synonym Qualifier

Descriptive name given to a specific Trial Arm (e.g., Low Dose, Mid Dose, 10 mg/kg/day dose).

Req

TAETORD

Order of Element within Arm

Num


Timing

Number that provides the order of the planned Element within the Arm. This value should be an integer.

Req

ETCD

Element Code

Char


Record Qualifier

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

TABRANCH

Branch

Char


Rule

Conditions subjects meet, occurring at the end of an Element, which cause an Arm to branch off from other Arms (e.g., randomization to "PRODUCT X").

Perm

TATRANS

Transition Rule

Char


Rule

If the study/trial design allows for a subject to transition to an Element other than the next sequential Element, as defined by TAETORD, then the conditions for transitioning to those other Elements, as well as the alternative Element sequences, are specified in this rule (e.g., TATRANS = 'Subject with Hypoactivity Transitions to Rest Period to Product Exposure 2').

Perm

EPOCH

Trial Epoch

Char


Timing

Name of the study Epoch with which this Element of the Arm is associated (e.g., Screen). Equivalent to 'Phase' or 'Period'.

Exp