myCSG © |Area: SDTM| Concept: DV : Protocol Deviations | Lesson: L101 : Protocol Deviations - L101 |

  • Sample programming of SDTM DV domain
  • Deviation Term when more than 200 characters is split into separate variables
  • Dynamic approach of splitting DVTERM is used
  • Study days are created
  • Sequence variable is created

PROTDEV : Protocol Deviations
Question Response
Description of protocol deviation
[TERM]

Start date of deviation
[DVSTDAT_RAW]

End date of deviation
[DVENDAT_RAW]

Is this a major deviation
[MAJOR]


Yes
No
Coded term
[CODED]




SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_PROTDEV
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'DV'
_ USUBJID Unique Subject Identifier Char Populate by concatenating the text "statschoice-" as a prefix to the value in SUBJECT variable.
_ 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
_ 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.
_ DVDECOD Protocol Deviation Coded Term Char Populate with the values from CODED variable.
_ DVSTDTC Start Date/Time of Deviation Char Populate using DVSTDAT_RAW after converting to ISO8601 format.
_ DVENDTC End Date/Time of Deviation Char NA Populate using DVENDAT_RAW after converting to ISO8601 format.
_ DVSTDY Study Day of Start of Deviation Event Num Populate the study day for DVSTDTC.
_ DVENDY Study Day of End of Observation Num Populate the study day for DVENDTC.
x DVTERM1 Protocol Deviation Term Char See derivation alogirthm specified in DVTERM variable derivation.
x DVMAJOR Major Event? Char Populate with the values from MAJOR variable.
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