myCSG © |Area: SDTM| Concept: DD : Death Details | Lesson: L101 : Death Details - date of death, autopsy, primary and secondary causes of death |

 

Background
  • In some clinical trials, we may have to collect data about diagnosis of the cause of death for a subject
  • Some example data points are:
    • Autopsy Indicator
    • Hospitalized at Time of Death Indicator
    • Information Source for Cause of Death
    • Location of Death
    • Primary Cause of Death
    • Secondary Cause of Death
  • SDTM standard has a standard domain for capturing these findings - "Death Details (DD)"
  • DD dataset belongs to Findings class and has an expected record structure of 'One record per finding per subject'

 

What type of information is typically collected or presented?
  • Date of assessment
  • Short name of the test
  • Name of the test
  • Result/finding
    • in original units
    • in standard units
  • Evaluator of the response/finding
 
Death Details, Primary cause of death, Secondary cause of death, Autopsy indicator

Lesson description will be added soon

DD_DEATH : Death details
Question Response
Date of collection
[DDDAT]
Autopsy performed
[AUTOPSY]

Yes
No
Primary cause of death
[PRMCAUS]

Study indication
Other
Specify, if other
[PRMCAUSSP]
Secondary cause of death
[SECCAUS]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_DD_DEATH
_ STUDYID Study Identifier Char Set to 'statschoice'
_ DOMAIN Domain Abbreviation Char Set to 'DD'
_ USUBJID Unique Subject Identifier Char Concatenate dd_death.PROJECT and dd_death.SUBJECT with a hyphen in between.
_ DDSEQ Sequence Number Num Sort the records by USUBJID, DDTESTCD, DDDTC and assign as 1 on the first record of each subject and increment by 1 for each subsequent record for that subject.
_ DDTESTCD Death Detail Assessment Short Name Char Create one record for each test collected.
Populate as 'AUTOPIND' when creating the record for field dd_death.AUTOPSY
Populate as 'PRCDTH' when creating the record for the field dd_death.PRMCAUS.
Populate as 'SECDTH' when creating the record for the field dd_death.SECCAUS.
_ DDTEST Death Detail Assessment Name Char Populate as 'Autopsy Indicator' when SDTM.DD.DDTESTCD=AUTOPIND.
Populate as 'Primary Cause of Death' when SDTM.DD.DDTESTCD=PRCDTH.
Populate as 'Secondary Cause of Death' when SDTM.DD.DDTESTCD=SECDTH.
_ DDORRES Result or Finding as Collected Char Populate using dd_death.AUTOPSY when creating the record for SDTM.DD.DDTESTCD=AUTOPIND.
Populate using dd_death.PRMCAUS when creating the record for SDTM.DD.DDTESTCD=PRMDTH
Populate using dd_death.SECCAUS when creating the record for SDTM.DD.DDTESTCD=SECDTH
_ DDSTRESC Character Result/Finding in Std Format Char Populate using SDTM.DD.DDORRES
_ DDDTC Date/Time of Collection Char Populate using dd_death.DDDAT in ISO 8601 format.
_ DDDY Study Day of Collection Num If the SDTM.DD.DDDTC is on or after reference start date then SDTM.DD.DDDTC-SDTM.DM.RFSTDTC +1. Else if date is before reference start date then assign as SDTM.DD.DDDTC-SDTM.DM.RFSTDTC.
Y PRCDTHSP Primary Death Cause Specify Char Populate using dd_death.PRMCAUSSP on the record where SDTM.DD.DDTESTCD is PRCDTH.
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