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Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 DV STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 DV DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 DV USUBJID Unique Subject Identifier Char Identifier Req Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4 DV DVSEQ Sequence Number Num Identifier Req Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 DV DVREFID Reference ID Char Identifier Perm Internal or external identifier.
6 DV DVSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF page.
7 DV DVTERM Protocol Deviation Term Char Topic Req 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.
8 DV DVDECOD Protocol Deviation Coded Term Char Synonym Qualifier Perm 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 Examples: SUBJECT NOT WITHDRAWN AS PER PROTOCOL, SELECTION CRITERIA NOT MET, EXCLUDED CONCOMITANT MEDICATION, TREATMENT DEVIATION.
9 DV DVCAT Category for Protocol Deviation Char Grouping Qualifier Perm Category of the protocol deviation criterion.
10 DV DVSCAT Subcategory for Protocol Deviation Char Grouping Qualifier Perm A further categorization of the protocol deviation.
11 DV EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the deviation. Examples: TREATMENT PHASE, SCREENING, and FOLLOW-UP.
12 DV DVSTDTC Start Date/Time of Deviation Char ISO 8601 Timing Perm Start date/time of deviation represented in ISO 8601 character format.
13 DV DVENDTC End Date/Time of Deviation Char ISO 8601 Timing Perm End date/time of deviation represented in ISO 8601 character format.