Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
|---|
STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
DOMAIN | Domain Abbreviation | Char | SE | Identifier | Two-character abbreviation for the domain. | Req |
USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. | Req |
SESEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a USUBJID within a domain. May be any valid number. | Req |
ETCD | Element Code | Char |
| Topic | ETCD (the companion to ELEMENT) is limited to 8 characters and does not have special character restrictions. | Req |
ELEMENT | Description of Element | Char |
| Synonym Qualifier | The name of the Element.. | Perm |
SESTDTC | Start Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | Start date/time for an Element for each subject, in ISO 8601 format. | Req |
SEENDTC | End Date/Time of Element | Char | ISO 8601 datetime or interval | Timing | End date/time for an Element for each subject, in ISO 8601 format. | Exp |
SEUPDES | Description of Unplanned Element | Char |
| Synonym Qualifier | Description of what happened to the subject during an unplanned Element. Used only if ETCD has the value of UNPLAN. | Perm |