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ICH ICSR Implementation Guide 12 April 2013
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Table8: International Standard Code Set OIDs
Element id Element Name
Coding
Scheme
Name
OID Reference
C.2.r.3 Reporter's Country Code
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
C.3.4.5 Sender's Country Code
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
C.5.1.r.2 Study Registration Country
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
D.5 Sex ISO 5218 1.0.5218
D.10.6 Sex of Parent ISO 5218 1.0.5218
E.i.1.1b Reaction /Event as Reported by
the Primary Source Language
ISO 639-
2/RA
(alpha-3)
1.0.639.2
E.i.9
Identification of the Country Where
the Reaction /Event Occurred
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
F.r.3.3 Test Result (unit) UCUM 2.16.840.1.113883.6.8
G.k.2.4 Identification of the Country Where
the Drug Was Obtained
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
G.k.3.2
Country of Authorisation /
Application
ISO 3166
Part 1
(alpha-2)
1.0.3166.1.2.2
H.5.r.1b Case Summary and Reporter’s
Comments Language
ISO 639-
2/RA
(alpha-3)
1.0.639.2
There is one exception not included in the table above. The identifier used in the ‘Sender's
(case) Safety Report Unique Identifier’ (C.1.1) and the ‘Worldwide Unique Case Identification
Number’ (C.1.8.1), is not listed as it is not exclusively coded using ISO 3166 Part
1.Nevertheless, it does reference the ISO Country Code system in its construction see the user
guidance for C.1.1 for more details.
3.2.3.1 Use of ISO 3166 Country Codes
Multiple data elements within the ICSR identify countries, either in relation to the drug, the
event, the sender or the reporter.E2B (R3) references ISO 3166-1 alpha-2, in the data elements
which capture country codes.