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ICH ICSR Implementation Guide 12 April 2013
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C.1.1 Sender’s (case) Safety Report Unique Identifier
User Guidance This data element contains an identifier for the ICSR that is unique. The
value should be a concatenation of3 segments separated by a dash/hyphen:
‘country code-company or regulator name-report number’. Country code
is the 2-letter ISO 3166 part 1 code (ISO 3166-1 alpha-2) corresponding to
the country of the primary source of the report (C.2.r.3) in exceptional
circumstances where the country of primary source is unknown, the
country where the reaction occurred (E.i.9) should be used to indicate the
country code. The company or regulator name is an internationally unique
abbreviation or code for the sender’s organisation the use of a ‘-
‘ (dash/hyphen) should be avoided in this segment. The report number is
the organisation’s international case number.
For example, a report transmitted from a company to a regulatory
authority concerning a case from France would populate C.1.1 with ‘FR-
companyname-12345’ where 12345 is that company’s unique case report
number.
When the same sender retransmits the same case (e.g. to transmit follow-
up information), C.1.1 usually remains constant. Exceptions are:
In the case of an organisational change, (e.g. a merger between
companies or a name change), follow-up reports can be identified
in C.1.1 by the identifier of the newly named organisation.
In the case of changes of country code for primary source for
regulatory purposes (C.2.r.3) or the country where the reaction
occurred (E.i.9), C.1.1 can be changed.
However, the ‘Worldwide Unique Case Identification Number’ (C.1.8.1)
used in any previous transmissions of the case should always remain the
same (See the user guidance for C.1.8).
Other retransmitters should replace this value with their own unique
identifier.
Conformance Required
Data Type 100AN
OID 2.16.840.1.113883.3.989.2.1.3.1
Value Allowed Free text (country code-company or regulator name-report number)
Business Rule(s)
A two character country code will be used in all instances for the country
component of the Unique Identifier. The country code EU exists in the
ISO 3166 country code list as an exceptional reservation code to support
any application that needs to represent the name European Union. In this
case, ‘EU’ will be accepted as the country code.
The format of C.1.1 ensures a unique report identifier for the sender of
particular ICSR.
The use of a ‘-’ (dash/hyphen) should be avoided in the ‘company or
regulator name’.
Both the ‘Sender's (case) Safety Report Unique Identifier’ (C.1.1) and the
ICH ICSR Implementation Guide 12 April 2013
-46-
C.1.1 Sender’s (case) Safety Report Unique Identifier
User Guidance This data element contains an identifier for the ICSR that is unique. The
value should be a concatenation of3 segments separated by a dash/hyphen:
‘country code-company or regulator name-report number’. Country code
is the 2-letter ISO 3166 part 1 code (ISO 3166-1 alpha-2) corresponding to
the country of the primary source of the report (C.2.r.3) in exceptional
circumstances where the country of primary source is unknown, the
country where the reaction occurred (E.i.9) should be used to indicate the
country code. The company or regulator name is an internationally unique
abbreviation or code for the sender’s organisation the use of a ‘-
‘ (dash/hyphen) should be avoided in this segment. The report number is
the organisation’s international case number.
For example, a report transmitted from a company to a regulatory
authority concerning a case from France would populate C.1.1 with ‘FR-
companyname-12345’ where 12345 is that company’s unique case report
number.
When the same sender retransmits the same case (e.g. to transmit follow-
up information), C.1.1 usually remains constant. Exceptions are:
In the case of an organisational change, (e.g. a merger between
companies or a name change), follow-up reports can be identified
in C.1.1 by the identifier of the newly named organisation.
In the case of changes of country code for primary source for
regulatory purposes (C.2.r.3) or the country where the reaction
occurred (E.i.9), C.1.1 can be changed.
However, the ‘Worldwide Unique Case Identification Number’ (C.1.8.1)
used in any previous transmissions of the case should always remain the
same (See the user guidance for C.1.8).
Other retransmitters should replace this value with their own unique
identifier.
Conformance Required
Data Type 100AN
OID 2.16.840.1.113883.3.989.2.1.3.1
Value Allowed Free text (country code-company or regulator name-report number)
Business Rule(s)
A two character country code will be used in all instances for the country
component of the Unique Identifier. The country code EU exists in the
ISO 3166 country code list as an exceptional reservation code to support
any application that needs to represent the name European Union. In this
case, ‘EU’ will be accepted as the country code.
The format of C.1.1 ensures a unique report identifier for the sender of
particular ICSR.
The use of a ‘-’ (dash/hyphen) should be avoided in the ‘company or
regulator name’.
Both the ‘Sender's (case) Safety Report Unique Identifier’ (C.1.1) and the