Subject_Autopsy data set

Data Series Title Description Location in Oracle Argus Safety
AutopsyCauseOfDeath Cause of death as determined by autopsy. This can be a repeating itemset. Map to the user-entered verbatim or to the encoded MedDRA lower-level term. Case Form / Patient / Death / Autopsy Results / Preferred Term Case Form / Events / Seriousness Criteria / Death / Details / Autopsy Results / Preferred Term
AutopsyCauseOfDeath MedDRAVersion Version of MedDRA used to code the autopsy cause of death if the autopsy cause of death is mapped to a lower-level term.

Note:

If AutopsyCauseOfDeath is mapped to the user-entered cause, do not map this field.
For items to be encoded in Oracle Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Oracle Argus Safety.