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C.1.8 Worldwide Unique Case Identification
Both C.1.8.1 and C.1.8.2 should always be populated and should never be changed in any
subsequent re-transmission.
When a sender has not previously received the ICSR in an electronic format (e.g. the
information was taken from a paper CIOMS, journal article, etc.) and thus creates the ‘initial’
electronic ICSR, the identifiers (content and format) in C.1.1 and C.1.8.1 are identical.
Retransmitters should use their own sender’s (case) safety report unique identifier in data
element C.1.1, but not change the values in data elements C.1.8.1 and C.1.8.2.
When a regulator is the initial sender, C.1.8.2 should be flagged as 1=Regulator.
When an entity other than a regulator is the initial sender, C.1.8.2 should be flagged as 2=Other.
C.1.8.1 Worldwide Unique Case Identification Number
User Guidance See Section C.1.8.
Because the data elements used to generate this identification number may
change over time (e.g. country code may become non-current), the
receiver should accept the value in this data element as is and not apply
particular business validation rules.
Conformance Required
Data Type 100AN
OID 2.16.840.1.113883.3.989.2.1.3.2
Value Allowed Free text (See C.1.1 user guidance for format)
Business Rule(s)
Both the ‘Sender's (case) Safety Report Unique Identifier’ (C.1.1) and the
‘Worldwide Unique Case Identification’ (C.1.8) data elements are mapped
to the repeatable XML attributeid in the ‘investigationEvent’ entity in
the HL7 ICSR model. (See the Reference Instance)ICH uses two values -
‘2.16.840.1.113883.3.989.2.1.3.1’ and ‘2.16.840.1.113883.3.989.2.1.3.2’
in the root portion of the investigationEvent.id to distinguish C.1.1 and
C.1.8.
The following notation will be used to represent C.1.1:
id extension="country code-company name-report no" root="
2.16.840.1.113883.3.989.2.1.3.1 "/
The following notation will be used to represent C.1.8:
id extension="country code-company name-report no" root="
2.16.840.1.113883.3.989.2.1.3.2"/
Although the attribute id can repeat in the message, but there must be a
single instance of the id attribute with the root value of
‘2.16.840.1.113883.3.989.2.1.3.2 ‘ for a particular case safety report.
ICH ICSR Implementation Guide 12 April 2013
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C.1.8 Worldwide Unique Case Identification
Both C.1.8.1 and C.1.8.2 should always be populated and should never be changed in any
subsequent re-transmission.
When a sender has not previously received the ICSR in an electronic format (e.g. the
information was taken from a paper CIOMS, journal article, etc.) and thus creates the ‘initial’
electronic ICSR, the identifiers (content and format) in C.1.1 and C.1.8.1 are identical.
Retransmitters should use their own sender’s (case) safety report unique identifier in data
element C.1.1, but not change the values in data elements C.1.8.1 and C.1.8.2.
When a regulator is the initial sender, C.1.8.2 should be flagged as 1=Regulator.
When an entity other than a regulator is the initial sender, C.1.8.2 should be flagged as 2=Other.
C.1.8.1 Worldwide Unique Case Identification Number
User Guidance See Section C.1.8.
Because the data elements used to generate this identification number may
change over time (e.g. country code may become non-current), the
receiver should accept the value in this data element as is and not apply
particular business validation rules.
Conformance Required
Data Type 100AN
OID 2.16.840.1.113883.3.989.2.1.3.2
Value Allowed Free text (See C.1.1 user guidance for format)
Business Rule(s)
Both the ‘Sender's (case) Safety Report Unique Identifier’ (C.1.1) and the
‘Worldwide Unique Case Identification’ (C.1.8) data elements are mapped
to the repeatable XML attributeid in the ‘investigationEvent’ entity in
the HL7 ICSR model. (See the Reference Instance)ICH uses two values -
‘2.16.840.1.113883.3.989.2.1.3.1’ and ‘2.16.840.1.113883.3.989.2.1.3.2’
in the root portion of the investigationEvent.id to distinguish C.1.1 and
C.1.8.
The following notation will be used to represent C.1.1:
id extension="country code-company name-report no" root="
2.16.840.1.113883.3.989.2.1.3.1 "/
The following notation will be used to represent C.1.8:
id extension="country code-company name-report no" root="
2.16.840.1.113883.3.989.2.1.3.2"/
Although the attribute id can repeat in the message, but there must be a
single instance of the id attribute with the root value of
‘2.16.840.1.113883.3.989.2.1.3.2 ‘ for a particular case safety report.