54
ICH ICSR Implementation Guide 12 April 2013
-55-
OID 2.16.840.1.113883.3.989.2.1.1.5
Value Allowed 1=Nullification
2=Amendment
Business Rule(s)
C.1.11.2 Reason for Nullification /Amendment
User Guidance This item should be used to indicate the reason why a previously
transmitted ICSR is either considered completely void (nullified) (for
example when the whole case was found to be erroneous), or amended
(for example when, after an internal review or according to an expert
opinion, some items have been modified, such as adverse reaction/event
terms, seriousness, seriousness criteria or causality assessment). It is
important to use the same Worldwide Unique Identifier previously
submitted in C.1.8.1. The date originally reported in C.1.5 should not be
changed in an amended report.
Conformance Optional, but required when C.1.11.1 is populated.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-55-
OID 2.16.840.1.113883.3.989.2.1.1.5
Value Allowed 1=Nullification
2=Amendment
Business Rule(s)
C.1.11.2 Reason for Nullification /Amendment
User Guidance This item should be used to indicate the reason why a previously
transmitted ICSR is either considered completely void (nullified) (for
example when the whole case was found to be erroneous), or amended
(for example when, after an internal review or according to an expert
opinion, some items have been modified, such as adverse reaction/event
terms, seriousness, seriousness criteria or causality assessment). It is
important to use the same Worldwide Unique Identifier previously
submitted in C.1.8.1. The date originally reported in C.1.5 should not be
changed in an amended report.
Conformance Optional, but required when C.1.11.1 is populated.
Data Type 2000AN
OID None
Value Allowed Free text
Business Rule(s)