| # | 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. |
|