SDTMIG v3.4 Metadata Check for Domain Specification Table 1.4.1
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Release Notes
Clinical encounter number. Numeric version of VISIT, used for sorting.
Req
VISIT
Visit Name
Char
Synonym Qualifier
Description of clinical encounter. This is often defined in the protocol. Used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.
Req
VISITDY
Planned Study Day of Visit
Num
Timing
Planned study day of VISIT. Due to its sequential nature, used for sorting.
Perm
ARMCD
Planned Arm Code
Char
*
Record Qualifier
ARMCD is limited to 20 characters and does not have special character restrictions. The maximum length of ARMCD is longer than 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.
If the timing of visits for a trial does not depend on which arm a subject is in, then ARMCD should be null.
Exp
ARM
Description of Planned Arm
Char
*
Synonym Qualifier
Name given to an arm or treatment group.
If the timing of visits for a trial does not depend on which arm a subject is in, then Arm should be left blank.
Perm
TVSTRL
Visit Start Rule
Char
Rule
Rule describing when the visit starts, in relation to the sequence of elements.
Req
TVENRL
Visit End Rule
Char
Rule
Rule describing when the visit ends, in relation to the sequence of elements.
Perm
1In this column, an asterisk (*) indicates that the variable may be subject to controlled terminology. CDISC/NCI codelist values are enclosed in parentheses.