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. | |
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. |