Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 DV 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 DV 2 DOMAIN Domain Abbreviation Char DV Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 DV 3 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
SDTMIG 3.3 DV 4 DVSEQ Sequence Number Num Identifier Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number. Req
SDTMIG 3.3 DV 5 DVREFID Reference ID Char Identifier Internal or external identifier. Perm
SDTMIG 3.3 DV 6 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
SDTMIG 3.3 DV 7 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
SDTMIG 3.3 DV 8 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 Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION".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
SDTMIG 3.3 DV 9 DVCAT Category for Protocol Deviation Char Grouping Qualifier Category of the protocol deviation criterion. Perm
SDTMIG 3.3 DV 10 DVSCAT Subcategory for Protocol Deviation Char Grouping Qualifier A further categorization of the protocol deviation. Perm
SDTMIG 3.3 DV 11 TAETORD Planned Order of Element within Arm Num Timing Number that gives the planned order of the Element within the Arm. Perm
SDTMIG 3.3 DV 12 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the start date/time of the deviation. Examples: "TREATMENT", "SCREENING", "FOLLOW-UP". Perm
SDTMIG 3.3 DV 13 DVSTDTC Start Date/Time of Deviation Char ISO 8601 Timing Start date/time of deviation represented in ISO 8601 character format. Perm
SDTMIG 3.3 DV 14 DVENDTC End Date/Time of Deviation Char ISO 8601 Timing End date/time of deviation represented in ISO 8601 character format. Perm
SDTMIG 3.3 DV 15 DVSTDY Study Day of Start of Deviation Event Num Timing Study day of start of event relative to the sponsor-defined RFSTDTC. Perm
SDTMIG 3.3 DV 16 DVENDY Study Day of End of Observation Num Timing Study day of end of event relative to the sponsor-defined RFSTDTC. Perm