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ICH ICSR Implementation Guide 12 April 2013
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D.9.2.r.2 Reported Cause(s) of Death (free text)
User Guidance This data element captures the original reporter's words and/or short
phrases used to describe the cause of death. Text should be provided in an
English translation for international transmission.
Conformance Optional, but required if D.9.2.r.1 is populated.
Data Type 250AN
OID None
Value Allowed Free text
Business Rule(s)
D.9.3 Was Autopsy Done?
User Guidance This data element indicates if an autopsy was done.
Conformance Optional, but required if D.9.1 is populated.
Data Type Boolean
OID None
Value Allowed false
true
nullFlavor: ASKU, NASK, UNK
Business Rule(s)
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.9.4.r Autopsy-determined Cause(s) of Death (repeat as necessary)
D.9.4.r.1a MedDRA Version for Autopsy-determined Cause(s) of Death
User Guidance This data element captures the MedDRA version for D.9.4.r.1b.
Conformance Optional, but required if D.9.4.r.1b is populated.
Data Type 4AN
OID None
Value Allowed Numeric and ‘. ‘(dot)
Business Rule(s)
Only 1 MedDRA version is allowed per ICSR.
For MedDRA version 15.1 value allowed is ‘15.1’.
D.9.4.r.1b Autopsy-determined Cause(s) of Death (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the autopsy-
determined cause of death.
Conformance Optional, but required if D.9.4.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)