51
ICH ICSR Implementation Guide 12 April 2013
-52-
Retransmitters should use their own ‘Sender’s (case) Safety Report Unique
Identifier’ (C.1.1), but must not change C.1.8.1 and C.1.8.2.
C.1.8.2 First Sender of This Case
User Guidance This data element is used to identify the type of sender that created and
transmitted the original electronic ICSR.
When a regulator is the initial sender, C.1.8.2 should be flagged as
‘Regulator’.
When an entity other than a regulator is the initial sender, C.1.8.2 should
be flagged as ‘Other’.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.3
Value Allowed 1=Regulator
2=Other
Business Rule(s)
C.1.9 Other Case Identifiers
C.1.9.1 Other Case Identifiers in Previous Transmissions
User Guidance This data element should be completed only if the answer is ‘true’. In the
event that the ICSR either has been exchanged by the two parties in the
past using a different identifier or that it is exchanged simultaneously with
a different identifier, this other identifier should be listed in data element
C.1.9.1.r.2 and the organisations name should be captured in data element
C.1.9.1.r.1.
Conformance Required
Data Type Boolean
OID None
Value Allowed true
nullFlavor: NI
Business Rule(s)
False is not a value allowed for this data element. This mandatory data
element should either be ‘true’ or ‘nullFlavor’.
ICH ICSR Implementation Guide 12 April 2013
-52-
Retransmitters should use their own ‘Sender’s (case) Safety Report Unique
Identifier’ (C.1.1), but must not change C.1.8.1 and C.1.8.2.
C.1.8.2 First Sender of This Case
User Guidance This data element is used to identify the type of sender that created and
transmitted the original electronic ICSR.
When a regulator is the initial sender, C.1.8.2 should be flagged as
‘Regulator’.
When an entity other than a regulator is the initial sender, C.1.8.2 should
be flagged as ‘Other’.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.3
Value Allowed 1=Regulator
2=Other
Business Rule(s)
C.1.9 Other Case Identifiers
C.1.9.1 Other Case Identifiers in Previous Transmissions
User Guidance This data element should be completed only if the answer is ‘true’. In the
event that the ICSR either has been exchanged by the two parties in the
past using a different identifier or that it is exchanged simultaneously with
a different identifier, this other identifier should be listed in data element
C.1.9.1.r.2 and the organisations name should be captured in data element
C.1.9.1.r.1.
Conformance Required
Data Type Boolean
OID None
Value Allowed true
nullFlavor: NI
Business Rule(s)
False is not a value allowed for this data element. This mandatory data
element should either be ‘true’ or ‘nullFlavor’.