SDTM v2.0 Metadata Check for Class and Dataset Specification Table 1.4.0
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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 "SM". | ||||
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 | SMSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness of subject records. Should be assigned to be consistent with chronological order. | ||||||
5 | MIDS | Disease Milestone Instance Name | Char | Topic | Name of the specific disease milestone. For disease milestones that can occur multiple times, the name will end with a sequence number. | "HYPO1" | |||||
6 | MIDSTYPE | Disease Milestone Type | Char | Record Qualifier | The type of disease milestone. | "HYPOGLYCEMIC EVENT" | |||||
7 | SMSTDTC | Start Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | Start date or start date and time of milestone instance (if milestone is an intervention or event), or date of milestone if the milestone is a finding. | |||||
8 | SMENDTC | End Date/Time of Milestone | Char | ISO 8601 datetime or interval | Timing | End date/time of disease milestone Instance. | |||||
9 | SMSTDY | Study Day of Start of Milestone | Num | Timing | Study day of start of disease milestone instance, relative to the sponsor-defined RFSTDTC. | ||||||
10 | SMENDY | Study Day of End of Milestone | Num | Timing | Study day of end of disease milestone instance, relative to the sponsor-defined RFSTDTC. |
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