| Variable Name | Variable Label | Type | Controlled Terms, Codelist or Format1 | Role | CDISC Notes | Core |
|---|
| STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study. | Req |
| DOMAIN | Domain Abbreviation | Char | DV | 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 |
| DVSEQ | Sequence Number | Num |
| Identifier | Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number. | Req |
| DVREFID | Reference ID | Char |
| Identifier | Internal or external identifier. | Perm |
| DVSPID | Sponsor-Defined Identifier | Char |
| Identifier | Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF page. | Perm |
| DVTERM | Protocol Deviation Term | Char |
| Topic | Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "TREATMENT DEVIATION"). | Req |
| DVDECOD | Protocol Deviation Coded Term | Char | * | Synonym Qualifier | Controlled terminology for the name of the protocol deviation. Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION". | Perm |
| DVCAT | Category for Protocol Deviation | Char | * | Grouping Qualifier | Category of the protocol deviationcriterion. | Perm |
| DVSCAT | Subcategory for Protocol Deviation | Char | * | Grouping Qualifier | A further categorization of the protocol deviation. | Perm |
| TAETORD | Planned Order of Element within Arm | Num |
| Timing | Number that gives the planned order of the element within the arm. | Perm |
| EPOCH | Epoch | Char | (EPOCH) | Timing | Epoch associated with the start date/time of the deviation. Examples: "TREATMENT", "SCREENING", "FOLLOW-UP". | Perm |
| DVSTDTC | Start Date/Time of Deviation | Char | ISO 8601 datetime or interval | Timing | Start date/time of deviation represented in ISO 8601 character format. | Perm |
| DVENDTC | End Date/Time of Deviation | Char | ISO 8601 datetime or interval | Timing | End date/time of deviation represented in ISO 8601 character format. | Perm |
| DVSTDY | Study Day of Start of Deviation Event | Num |
| Timing | Study day of start of event relative to the sponsor-defined RFSTDTC. | Perm |
| DVENDY | Study Day of End of Deviation Event | Num |
| Timing | Study day of end of event relative to the sponsor-defined RFSTDTC. | Perm |