Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | SV | Identifier | Two-character abbreviation for the domain most relevant to the observation. The domain abbreviation is also used as a prefix for variables to ensure uniqueness when datasets are merged. | Req |
USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
VISITNUM | Visit Number | Num |
| Topic | - An assigned numeric identifier that aligns to the chronological order of an encounter.
- Numeric version of VISIT, used for sorting.
| Req |
VISIT | Visit Name | Char |
| Synonym Qualifier | - The label for a protocol-defined encounter.
- May be used in addition to VISITNUM and/or VISITDY.
| Perm |
SVPRESP | Pre-specified | Char | (NY) | Variable Qualifier | Used to indicate whether the visit was planned (i.e., visits specified in the TV domain). Value is "Y" for planned visits, null for unplanned visits. | Exp |
SVOCCUR | Occurrence | Char | (NY) | Record Qualifier | Used to record whether a planned visit occurred. The value is null for unplanned visits. | Exp |
SVREASOC | Reason for Occur Value | Char |
| Record Qualifier | The reason for the value in SVOCCUR. If SVOCCUR="N", SVREASOC is the reason the visit did not occur. | Perm |
SVCNTMOD | Contact Mode | Char | (CNTMODE) | Record Qualifier | The way in which the visit was conducted. Examples: "IN PERSON", "TELEPHONE CALL", "IVRS". | Perm |
SVEPCHGI | Epi/Pandemic Related Change Indicator | Char | (NY) | Record Qualifier | Indicates whether the visit was changed due to an epidemic or pandemic. | Perm |
VISITDY | Planned Study Day of Visit | Num |
| Timing | Planned study day of VISIT. Should be an integer. | Perm |
SVSTDTC | Start Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | Start date/time of an observation represented in IS0 8601 character format. | Exp |
SVENDTC | End Date/Time of Observation | Char | ISO 8601 datetime or interval | Timing | End date/time of the observation represented in IS0 8601 character format. | Exp |
SVSTDY | Study Day of Start of Observation | Num |
| Timing | Actual study day of start of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm |
SVENDY | Study Day of End of Observation | Num |
| Timing | Actual study day of end of observation expressed in integer days relative to the applicant-defined RFSTDTC in Demographics. | Perm |
SVUPDES | Description of Unplanned Visit | Char |
| Record Qualifier | Description of what happened to the subject during an unplanned visit. Only populated for unplanned visits. | Perm |