Description

A trial design domain that contains each planned arm in the trial.

ta.xpt, Trial Arms — Trial Design. One record per planned Element per Arm, Tabulation.


Specification

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


Assumptions

  1. The Trial Arms (TA) dataset provides a record of the complete planned sequence of elements for each arm.
  2. ARM and ARMCD values in Demographics (DM) and TA must coincide (ARM and ARMCD are defined as the planned trial arms in TA, and the planned arms are then applied to subjects in DM).
  3. TAETORD is an integer and is used to order the elements within an arm. In general the value of TAETORD is "1" for the first element in each arm, "2" for the second element in each arm, and so on. Occasionally, the sequential order of the elements may not be known in advance, in which case the TA domain is populated after the study has been conducted (e.g., for an unknown number of cycles of product exposure and recovery in a group). Although the values of TAETORD need not always be consecutive, the values must always be populated according to the correct order of the elements within an arm, with the first element equivalent to the lowest value of TAETORD and the last element equivalent to the highest value of TAETORD.
  4. The values of ETCD used in the TA dataset must match values for the same element in the Trial Elements (TE) dataset.
  5. The elements in each arm must be consecutive in time; it is not correct to leave any gaps in time between elements. If a multiday pause in product exposure is part of the study design, that should either be reflected within one of the existing element definitions, or a new element representing the lack of product exposure should be included.
  6. Elements in different arms with the same value of TAETORD may or may not happen at the same time, depending on the design of the study.
  7. The same element may occur more than once within an arm.
  8. TABRANCH describes the outcome of a branch decision point in the trial design for subjects in the arm. A branch decision point takes place between epochs and is associated with the element end, at which point the branching decision is made. For instance, if subjects are assigned to an arm where they receive Product A through a randomization at the end of element X, the value of TABRANCH for element X would be "Randomized to A".
  9. Branch decision points may be based on decision processes other than randomizations, such as clinical evaluations of disease response.
  10. There is usually some gap in time between the performance of a randomization and the start of randomized product exposure. However, in many studies this gap in time is small and it is not intended that subjects will leave the study between randomization and product exposure. In these circumstances, the study does not need to be modeled with this time period between randomization and start of product exposure as a separate element.
  11. TATRANS describes the decision points that may lead to a shortened path within an arm (e.g. if some elements within the arm are skipped). If an element does not end with a decision that could lead to a shortened path within the arm, then TATRANS will be null. If there is a decision being represented within the value of TATRANS, the TATRANS rule should be populated as an "if-then" statement (e.g., "If condition X is true, then go to element with TAETORD = Z").
  12. EPOCH is the conceptual basis for comparisons between arms. EPOCH is not strictly necessary for describing the sequence of elements in an arm path. The values of EPOCH should provide a description of a time period that is independent of the value of ARM.
  13. EPOCH should be assigned in such a way that elements from different arms with the same value of EPOCH are comparable in some sense (e.g., EPOCH="Exposure", where specific doses may be different across arms but the subjects are all being dosed in some manner).
  14. In vitro studies do not typically include trial arms.

« SEND Supplemental Qualifiers (SUPP--)

SEND Trial Elements (TE) »

  • No labels