| 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 | DS | 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 |
| DSSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| DSTERM | Reported Term for the Disposition Event | Char |
| Topic | DSTERM is the original term recorded for subject disposition. DSTERM is not under controlled terminology, but should be mapped to DSDECOD. | Req |
| DSDECOD | Standardized Disposition Term | Char | (DSDECOD) | Synonym Qualifier | Contains the result in a standard format. | Req |
| DSUSCHFL | Unscheduled Flag | Char | (NY) | Record Qualifier | Indicates whether the subject's disposition was unscheduled. If the subject's disposition was based upon a schedule defined in the protocol, this flag should be null. Expected values are Y or null. | Exp |
| VISITDY | Planned Study Day of Disposition | Num |
| Timing | Planned study day of collection. Should be an integer. VISITDY should be populated only when DSTERM represents a scheduled activity. | Perm |
| DSSTDTC | Date/Time of Disposition | Char | ISO 8601 datetime or interval | Timing | Date/Time of the disposition event, in ISO 8601 format. | Req |
| DSSTDY | Study Day of Disposition | Num |
| Timing | Study day of the disposition event, in integer days. The algorithm for calculations must be relative to the applicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
| DSNOMDY | Nominal Study Day for Tabulations | Num |
| Timing | Nominal study day used for grouping records for observations that may occur on different days into a single reported study day. Should be an integer. | Exp |
| DSNOMLBL | Label for Nominal Study Day | Char |
| Timing | A label for a given value of DSNOMDY as presented in the study report. Examples: Week 4, Day 28, Terminal Sac. | Perm |