| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|
| 1 | STUDYID | Study Identifier | Char |
| Identifier |
|
| C83082 | A sequence of characters used by the sponsor to uniquely identify the study. |
|
|
| 2 | DOMAIN | Domain Abbreviation | Char |
| Identifier |
|
| C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "SV". |
|
| 3 | USUBJID | Unique Subject Identifier | Char |
| Identifier |
|
| C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. |
|
|
| 4 | VISITNUM | Visit Number | Num |
| Topic |
|
| C83101 | An assigned numeric identifier that aligns to the chronological order of a clinical encounter. | Decimal numbering may be useful for inserting unplanned visits. Used for sorting. |
|
| 5 | VISIT | Visit Name | Char |
| Synonym Qualifier | VISITNUM |
| C171010 | The label for a protocol-defined clinical encounter. | May be used in addition to VISITNUM and/or VISITDY. |
|
| 6 | SVPRESP | Pre-Specified | Char |
| Variable Qualifier | VISITNUM |
|
|
| An indication that the visit is planned. Values should be "Y" or null. |
|
| 7 | SVOCCUR | Occurrence | Char |
| Record Qualifier |
|
|
|
| An indication as to whether a prespecified (planned) visit has occurred. |
|
| 8 | 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. |
|
| 9 | SVCNTMOD | Contact Mode | Char |
| Record Qualifier |
|
|
|
| The way in which the visit or contact was conducted. | "IN PERSON", "TELEPHONE", "IVRS". |
| 10 | SVEPCHGI | Epi/Pandemic Related Change Indicator | Char |
| Record Qualifier |
|
|
|
| Indicates whether the visit was changed due to an epidemic or pandemic. |
|
| 11 | VISITDY | Planned Study Day of Visit | Num |
| Timing |
|
| C171011 | The planned study day of a clinical encounter relative to the sponsor-defined reference start date. | The reference start date is RFSTDTC in Demographics. |
|
| 12 | SVSTDTC | Start Date/Time of Visit | Char | ISO 8601 datetime or interval | Timing |
|
|
|
| Start date or start date and time for a subject's visit. |
|
| 13 | SVENDTC | End Date/Time of Visit | Char | ISO 8601 datetime or interval | Timing |
|
|
|
| End date/time of a subject's visit. |
|
| 14 | SVSTDY | Study Day of Start of Visit | Num |
| Timing |
|
|
|
| Study day of start of visit relative to the sponsor-defined RFSTDTC. |
|
| 15 | SVENDY | Study Day of End of Visit | Num |
| Timing |
|
|
|
| Study day of end of visit relative to the sponsor-defined RFSTDTC. |
|
| 16 | SVUPDES | Description of Unplanned Visit | Char |
| Record Qualifier |
|
|
|
| Description of what happened to the subject during an unplanned visit. Null for protocol-defined visits. |
|