SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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# | 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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