SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than that for other "short" variables to accommodate the kind of values that are likely to be needed for crossover trials. For example, if ARMCD values for a 7-period crossover were constructed using 2-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20.
Req
ARM
Description of Planned Arm
Char
*
Synonym Qualifier
Name given to an arm or treatment group.
Req
TAETORD
Planned Order of Element within Arm
Num
Timing
Number that gives the order of the element within the arm.
Req
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.
Req
ELEMENT
Description of Element
Char
*
Synonym Qualifier
The name of the element. The same element may occur more than once within an arm.
Perm
TABRANCH
Branch
Char
Rule
Condition subject met, at a "branch" in the trial design at the end of this element, to be included in this arm (e.g., "Randomization to DRUG X").
Exp
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 (e.g., "Responders go to washout").
Name of the trial epoch with which this element of the arm is associated.
Req
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.