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ICH ICSR Implementation Guide 12 April 2013
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D.9 In Case of Death
D.9.1 Date of Death
User Guidance This data element captures the reported date of death for the patient. An
imprecise date can be used.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.9.2.r Reported Cause(s) of Death (repeat as necessary)
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each cause
of death term. For example, if two causes of death are reported, the first cause would be
described in items D.9.2.1.1 through D.9.2.1.2 and the other cause would be described in items
D.9.2.2.1 through D.9.2.2.2.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death
User Guidance This data element captures the MedDRA version for D.9.2.r.1b.
Conformance Optional, but required if D.9.2.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.9.2.r.1b Reported Cause(s) of Death (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the reported cause
of death.
Conformance Optional, but required if D.9.2.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-90-
D.9 In Case of Death
D.9.1 Date of Death
User Guidance This data element captures the reported date of death for the patient. An
imprecise date can be used.
Conformance Optional
Data Type Date /Time
OID None
Value Allowed See Appendix II for further information.
nullFlavor: MSK, ASKU, NASK
Business Rule(s)
Minimum precision required is the year (i.e. ‘CCYY’).
The date specified cannot refer to a future date.
Please see Section 3.3.6 for further guidance on the use of nullFlavor to
describe missing or non-transmitted information.
D.9.2.r Reported Cause(s) of Death (repeat as necessary)
The designation of ‘r’ in this section indicates that each item is repeatable and that it
corresponds to the same ‘r’ in all subsections. A separate block (r) should be used for each cause
of death term. For example, if two causes of death are reported, the first cause would be
described in items D.9.2.1.1 through D.9.2.1.2 and the other cause would be described in items
D.9.2.2.1 through D.9.2.2.2.
D.9.2.r.1a MedDRA Version for Reported Cause(s) of Death
User Guidance This data element captures the MedDRA version for D.9.2.r.1b.
Conformance Optional, but required if D.9.2.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.9.2.r.1b Reported Cause(s) of Death (MedDRA code)
User Guidance This data element captures the MedDRA LLT code for the reported cause
of death.
Conformance Optional, but required if D.9.2.r.1a is populated.
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)