ROWORDER SUPP VARIABLE_NAME VARIABLE_LABEL TYPE GENERAL_COMMENT FORM_PROTDEV
001 STUDYID Study Identifier Char Populate as 'MYCSG'
002 DOMAIN Domain Abbreviation Char Populate as 'DV'
003 USUBJID Unique Subject Identifier Char Populate by concatenating the text "MYCSG-" as a prefix to the value in SUBJECT variable.
004 DVSEQ Sequence Number Num Sort the records by USUBJID, DVTERM, DVSTDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject.

seq
005 DVTERM Protocol Deviation Term Char Populate using TERM variable. If there exists more than 200 characters in TERM variable, present only till the last breaking space before the 200th character. Populate the remaining text in DVTERM1 variable. Repeat the same logic and create as many DVTERMx variables as needed based on the number of characters in TERM variable.
006 DVDECOD Protocol Deviation Coded Term Char Populate with the values from CODED variable.
007 DVSTDTC Start Date/Time of Deviation Char Populate using DVSTDAT_RAW after converting to ISO8601 format.
008 DVENDTC End Date/Time of Deviation Char NA Populate using DVENDAT_RAW after converting to ISO8601 format.
009 DVSTDY Study Day of Start of Deviation Event Num Populate the study day for DVSTDTC.
010 DVENDY Study Day of End of Observation Num Populate the study day for DVENDTC.
011 x DVTERM1 Protocol Deviation Term Char See derivation alogirthm specified in DVTERM variable derivation.
012 x DVMAJOR Major Event? Char Populate with the values from MAJOR variable.