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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 control group).
Perm
TATRANS
Transition Rule
Char
Rule
If the study 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 Treatment 2').
Perm
EPOCH
Trial Epoch
Char
Timing
Name of the study Epoch with which this Element of the Arm is associated (e.g., Treatment, Screen). Equivalent to 'Phase' or 'Period.'