Trial Arms describes each planned arm in a trial. An arm is an ordered sequence of elements; the same element may occur more than once in a given arm. In order to accommodate complex trial designs, this dataset allows for rules for branching from one element to another when a choice is available, and a rule for transitions to allow a subject to skip ahead to another element rather than proceed linearly.

Note that although the same element may occur more than once within an arm, each occurrence would have a different value for TAETORD and EPOCH, and may have different values for TABRANCH and TATRANS.

Trial Arms—One Record per Planned Element per Arm

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 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 NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotesExamples
1STUDYIDStudy IdentifierChar
Identifier

C83082

A sequence of characters used by the sponsor to uniquely identify the study.



2DOMAINDomain AbbreviationChar
Identifier

C49558

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "TA".
3ARMCDPlanned Arm CodeChar
Topic

C83216A short sequence of characters that represents the planned arm to which the subject was assigned.ARMCD is limited to 20 characters and does not have special character restrictions.
4ARMDescription of Planned ArmChar
Synonym QualifierARMCD
C170984The name of the planned arm to which the subject was assigned.

5TAETORDPlanned Order of Element within ArmNum
Timing

C83438An assigned numeric identifier that gives the planned order of the element within the trial arm of the study.

6ETCDElement CodeChar
Record Qualifier



ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ETCD will need to serve as a variable name.
7ELEMENTDescription of ElementChar
Synonym QualifierETCD


The name of the element.
8TABRANCHBranchChar
Rule



Condition subjects meet, at a "branch" in the trial design at the end of this element, to be included in this arm."Randomization to DRUG X"
9TATRANSTransition RuleChar
Rule



If the trial design allows a subject to transition to an element other than the next element in sequence, then the conditions for transitioning to those other elements, and the alternative element sequences, are specified in this rule."Responders go to washout"
10EPOCHEpochChar
Timing

C71738A time period defined in the protocol with a study-specific purpose.The epoch associated with the value in ELEMENT and the value in ARMCD.


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