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E.i.9 Identification of the Country Where the Reaction /Event Occurred
User Guidance This data element captures the country where the reaction occurred. For
example a patient living in Country A experienced headache while
travelling in Country B this headache was suspected to be an adverse
drug reaction and was reported by a health professional in Country C.
The data element C.2.r.3 should be populated with Country C, and the
data element E.i.9 should be populated with Country B.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
Business Rule(s)
A two character country code will be used in all instances.
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.
F.r Results of Tests and Procedures Relevant to the Investigation of the Patient (repeat as
necessary)
This section captures the tests and procedures performed to diagnose or confirm the
reaction/event, including those tests done to investigate (exclude) a non-drug cause (e.g.
serologic tests for infectious hepatitis in suspected drug-induced hepatitis). Both positive and
negative results should be reported. While structured information is preferable, provisions are
made to transmit the information as free text.
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
test/procedure. For example, if two tests are reported, the first test would be described in items
F.1.1 through F.1.7, and the other test would be described in items F.2.1 through F.2.7.
ICH ICSR Implementation Guide 12 April 2013
-108-
E.i.9 Identification of the Country Where the Reaction /Event Occurred
User Guidance This data element captures the country where the reaction occurred. For
example a patient living in Country A experienced headache while
travelling in Country B this headache was suspected to be an adverse
drug reaction and was reported by a health professional in Country C.
The data element C.2.r.3 should be populated with Country C, and the
data element E.i.9 should be populated with Country B.
Conformance Optional
Data Type 2A
OID 1.0.3166.1.2.2
Value Allowed ISO 3166-1 alpha-2, EU
Business Rule(s)
A two character country code will be used in all instances.
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.
F.r Results of Tests and Procedures Relevant to the Investigation of the Patient (repeat as
necessary)
This section captures the tests and procedures performed to diagnose or confirm the
reaction/event, including those tests done to investigate (exclude) a non-drug cause (e.g.
serologic tests for infectious hepatitis in suspected drug-induced hepatitis). Both positive and
negative results should be reported. While structured information is preferable, provisions are
made to transmit the information as free text.
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
test/procedure. For example, if two tests are reported, the first test would be described in items
F.1.1 through F.1.7, and the other test would be described in items F.2.1 through F.2.7.