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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 TV STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 TV DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain
3 TV VISITNUM Visit Number Num Topic Req 1. Clinical encounter number 2. Numeric version of VISIT, used for sorting.
4 TV VISIT Visit Name Char Synonym Qualifier Perm 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY as a text description of the clinical encounter.
5 TV VISITDY Planned Study Day of Visit Num Timing Perm 1. Planned study day of VISIT. 2. Due to its sequential nature, used for sorting
6 TV ARMCD Planned Arm Code Char Record Qualifier Exp 1.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 seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. 2. If the timing of Visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null.
7 TV ARM Description of Planned Arm Char Synonym Qualifier Perm 1.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 seven-period crossover were constructed using two-character abbreviations for each treatment and separating hyphens, the length of ARMCD values would be 20. 2. If the timing of Visits for a trial does not depend on which ARM a subject is in, then ARMCD should be null.
8 TV TVSTRL Visit Start Rule Char Rule Req Rule describing when the Visit starts, in relation to the sequence of Elements.
9 TV TVENRL Visit End Rule Char Rule Perm Rule describing when the Visit ends, in relation to the sequence of Elements.