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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 SV STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 SV DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 SV USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 SV VISITNUM Visit Number Num Topic Req 1. Clinical encounter number. (Decimal numbering may be useful for inserting unplanned visits.) 2. Numeric version of VISIT, used for sorting.
5 SV 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.
6 SV VISITDY Planned Study Day of Visit Num Timing Perm Planned study day of the start of the visit based upon RFSTDTC in Demographics.
7 SV SVSTDTC Start Date/Time of Visit Char ISO 8601 Timing Exp Start date/time for a Visit.
8 SV SVENDTC End Date/Time of Visit Char ISO 8601 Timing Exp End date/time of a Visit.
9 SV SVSTDY Study Day of Start of Visit Num Timing Perm Study day of start of visit relative to the sponsor-defined RFSTDTC.
10 SV SVENDY Study Day of End of Visit Num Timing Perm Study day of end of visit relative to the sponsor-defined RFSTDTC.
11 SV SVUPDES Description of Unplanned Visit Char Synonym Qualifier Perm Description of what happened to the subject during an unplanned visit.