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ICH ICSR Implementation Guide 12 April 2013
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3.2.2 ICH Maintained Code Sets and Object Identifiers (OIDs) Created for the ICH ICSR
This section contains tables of Code Sets and OIDs relevant to this IG specifically created for
the ICH these code sets are maintained by or for ICH.
Table3: E2B (R3) data elements and ICH ICSR message Codes OIDs
Element id Element Name ICH OID
N.1.1 Type of Messages in Batch 2.16.840.1.113883.3.989.2.1.1.1
C.1.3 Type of Report 2.16.840.1.113883.3.989.2.1.1.2
C.1.8.2 First Sender of This Case 2.16.840.1.113883.3.989.2.1.1.3
C.1.11.1 Report Nullification /Amendment 2.16.840.1.113883.3.989.2.1.1.5
C.2.r.4 Qualification 2.16.840.1.113883.3.989.2.1.1.6
C.3.1 Sender Type 2.16.840.1.113883.3.989.2.1.1.7
C.5.4 Study Type Where Reaction(s) /
Event(s) Were Observed
2.16.840.1.113883.3.989.2.1.1.8
D.1.1.1 –
D.1.1.4
Source(s) of the Patient Medical
Record Number
2.16.840.1.113883.3.989.2.1.1.4
D.2.3 Patient Age Group (as per reporter) 2.16.840.1.113883.3.989.2.1.1.9
E.i.3.1 Term Highlighted by the Reporter 2.16.840.1.113883.3.989.2.1.1.10
E.i.7 Outcome of Reaction /Event at the
Time of Last Observation 2.16.840.1.113883.3.989.2.1.1.11
F.r.3.1 Test Result (code) 2.16.840.1.113883.3.989.2.1.1.12
G.k.1 Characterisation of Drug Role 2.16.840.1.113883.3.989.2.1.1.13
G.k.4.r.10.2b,
G.k.4.r.11.2b
Route of Administration TermID
(E2B(R2))
2.16.840.1.113883.3.989.2.1.1.14
G.k.8 Action(s) Taken with Drug 2.16.840.1.113883.3.989.2.1.1.15
G.k.9.i.4
Did Reaction Recur on Re-
Administration?
2.16.840.1.113883.3.989.2.1.1.16
G.k.10.r Additional Information on Drug
(coded) (repeat as necessary) 2.16.840.1.113883.3.989.2.1.1.17