| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
|
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
|
| ARMCD |
Planned Arm Code |
Char |
Topic |
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 seven-period crossover were constructed using
two-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"). |
Exp |
|
| EPOCH |
Epoch |
Char |
Timing |
Name of the Trial Epoch with which this Element of the Arm
is associated. |
Req |
|