Trial Visits describes the planned order and number of visits in the study. Trial Visits also describes the allowable or planned values for VISIT, VISITNUM, and VISITDY in the trial (which are subsequently used as timing variables for the collected study data), and rules for starting and ending each visit. In most blinded trials, the timing of visits is the same for all subjects in all arms. In the case where visits vary for each arm, there would be a separate record per visit per arm.
Trial Visits—One Record per Planned Trial Visit
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 "TV". | ||||
| 3 | VISITNUM | Visit Number | Num | Topic | C83101 | An assigned numeric identifier that aligns to the chronological order of a clinical encounter. | Numeric version of VISIT can be used for sorting. | ||||
| 4 | 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. | |||
| 5 | 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. | Due to its sequential nature can be used for sorting. | ||||
| 6 | ARMCD | Planned Arm Code | Char | Record Qualifier | C83216 | A short sequence of characters that represents the planned arm to which the subject was assigned. | ARMCD is limited to 20 characters and does not have special character restrictions. If the timing of visits for a trial does not depend on which Arm a subject is in, then ARMCD should be null. | ||||
| 7 | ARM | Description of Planned Arm | Char | Synonym Qualifier | ARMCD | C170984 | The name of the planned arm to which the subject was assigned. | ||||
| 8 | TVSTRL | Visit Start Rule | Char | Rule | Rule describing when the visit starts, in relation to the sequence of elements. | ||||||
| 9 | TVENRL | Visit End Rule | Char | Rule | Rule describing when the visit ends, in relation to the sequence of elements. |
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