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. |
Overview
Content Tools