| 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. Perhaps 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". The DVTERM values will map to the controlled terminology in DVDECOD, such as "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 Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION".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 deviation criterion. | 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 | Timing | Start date/time of deviation represented in ISO 8601 character format. | Perm |
DVENDTC | End Date/Time of Deviation | Char | ISO 8601 | 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 Observation | Num | | Timing | Study day of end of event relative to the sponsor-defined RFSTDTC. | Perm |