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 |