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. |