Subject Visits describes the actual start and end date/time for each visit of each individual subject. Planned trial visits are described in the Trial Design Model (see Section 5.1.4.1, Trial Visits). Because actual data does not always follow the plan, the SDTM allows for descriptions of unplanned visits for subjects (SVUPDES).
See the implementation guides for further guidance regarding use of additional identifier and timing variables.
Subject Visits
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | 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. |
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