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 Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "TA". | ||||
| 3 | ARMCD | Planned Arm Code | Char | Topic | C83216 | A 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. | ||||
| 4 | ARM | Description of Planned Arm | Char | Synonym Qualifier | ARMCD | C170984 | The name of the planned arm to which the subject was assigned. | ||||
| 5 | TAETORD | Planned Order of Element within Arm | Num | Timing | C83438 | An assigned numeric identifier that gives the planned order of the element within the trial arm of the study. | |||||
| 6 | ETCD | Element Code | Char | 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. | ||||||
| 7 | ELEMENT | Description of Element | Char | Synonym Qualifier | ETCD | The name of the element. | |||||
| 8 | TABRANCH | Branch | Char | 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" | |||||
| 9 | TATRANS | Transition Rule | Char | 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" | |||||
| 10 | EPOCH | Epoch | Char | Timing | C71738 | A 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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