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SUPPDV: Protocol Deviations Domain Supplemental Variables

Description Note


Variable Name Variable Label
STUDYID Study Identifier
RDOMAIN Related Domain Abbreviation
USUBJID Unique Subject Identifier
IDVAR Identifying Variable
IDVARVAL Identifying Variable Value
QNAM Qualifier Variable Name
QLABEL Qualifier Variable Label
QVAL Data Value


The following table enumerates the values in QNAM and QLABEL variables

DVRELAE Is Deviation Related to an Adverse Event?
DVREASON Reason for Deviation
DVRESOL Resulotion of Deviation
DVCONT Did Subject continued in Study?
DVSTDY Study Day of Start of Deviation
DVENDY Study Day of End of Deviation

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