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ICH ICSR Implementation Guide 12 April 2013
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Table4: E2B (R3) data elements and ICH ICSR message Codes OIDs (ICH constrained
UCUM codes)
Element id Element Name ICH OID
D.2.2b Age at Time of Onset of Reaction /
Event (unit)
2.16.840.1.113883.3.989.2.1.1.26
D.2.2.1b
Gestation Period When Reaction /
Event Was Observed in the Foetus
(unit)
2.16.840.1.113883.3.989.2.1.1.26
D.10.2.2b Age of Parent (unit) 2.16.840.1.113883.3.989.2.1.1.26
E.i.6b Duration of Reaction /Event (unit) 2.16.840.1.113883.3.989.2.1.1.26
G.k.2.3.r.3b Strength (unit) 2.16.840.1.113883.3.989.2.1.1.25
G.k.4.r.1b Dose (unit) 2.16.840.1.113883.3.989.2.1.1.25
G.k.4.r.3 Definition of the Time Interval Unit 2.16.840.1.113883.3.989.2.1.1.26
G.k.4.r.6b Duration of the Drug Administration
(unit) 2.16.840.1.113883.3.989.2.1.1.26
G.k.5b Cumulative Dose to First Reaction
(unit) 2.16.840.1.113883.3.989.2.1.1.25
G.k.6b Gestation Period at Time of Exposure
(unit) 2.16.840.1.113883.3.989.2.1.1.26
G.k.9.i.3.1b
Time Interval between Beginning of
Drug Administration and Start of
Reaction /Event (unit)
2.16.840.1.113883.3.989.2.1.1.26
G.k.9.i.3.2b
Time Interval between Last Dose of
Drug and Start of Reaction /Event
(unit)
2.16.840.1.113883.3.989.2.1.1.26
There is an exception for F.r.3.3 ‘Test Result’. ICH does not provide constrained UCUM
codes for this field to allow variety of units. UCUM codes can be selected from the original
UCUM list and OID is listed in the table 8.