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ICH ICSR Implementation Guide 12 April 2013
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Table 2: E2B (R3) data elements and MedDRA OIDs
Element id Element Name OID Reference
D.7.1.r.1b Medical History (disease /surgical
procedure /etc.) (MedDRA code) 2.16.840.1.113883.6.163
D.8.r.6b Indication (MedDRA code) 2.16.840.1.113883.6.163
D.8.r.7b Reaction (MedDRA code) 2.16.840.1.113883.6.163
D.9.2.r.1b Reported Cause(s) of Death
(MedDRA code) 2.16.840.1.113883.6.163
D.9.4.r.1b Autopsy-determined Cause(s) of
Death (MedDRA code) 2.16.840.1.113883.6.163
D.10.7.1.r.1b Medical History (disease /surgical
procedure /etc.) (MedDRA code) 2.16.840.1.113883.6.163
D.10.8.r.6b Indication (MedDRA code) 2.16.840.1.113883.6.163
D.10.8.r.7b Reactions (MedDRA code) 2.16.840.1.113883.6.163
E.i.2.1b Reactions /Event (MedDRA code) 2.16.840.1.113883.6.163
F.r.2.2b Test Name (MedDRA code) 2.16.840.1.113883.6.163
G.k.7.r.2b Indication (MedDRA code) 2.16.840.1.113883.6.163
H.3.r.1b
Sender's Diagnosis /Syndrome and /
or Reclassification of Reaction /Event
(MedDRA code)
2.16.840.1.113883.6.163
ICH ICSR Implementation Guide 12 April 2013
-26-
Table 2: E2B (R3) data elements and MedDRA OIDs
Element id Element Name OID Reference
D.7.1.r.1b Medical History (disease /surgical
procedure /etc.) (MedDRA code) 2.16.840.1.113883.6.163
D.8.r.6b Indication (MedDRA code) 2.16.840.1.113883.6.163
D.8.r.7b Reaction (MedDRA code) 2.16.840.1.113883.6.163
D.9.2.r.1b Reported Cause(s) of Death
(MedDRA code) 2.16.840.1.113883.6.163
D.9.4.r.1b Autopsy-determined Cause(s) of
Death (MedDRA code) 2.16.840.1.113883.6.163
D.10.7.1.r.1b Medical History (disease /surgical
procedure /etc.) (MedDRA code) 2.16.840.1.113883.6.163
D.10.8.r.6b Indication (MedDRA code) 2.16.840.1.113883.6.163
D.10.8.r.7b Reactions (MedDRA code) 2.16.840.1.113883.6.163
E.i.2.1b Reactions /Event (MedDRA code) 2.16.840.1.113883.6.163
F.r.2.2b Test Name (MedDRA code) 2.16.840.1.113883.6.163
G.k.7.r.2b Indication (MedDRA code) 2.16.840.1.113883.6.163
H.3.r.1b
Sender's Diagnosis /Syndrome and /
or Reclassification of Reaction /Event
(MedDRA code)
2.16.840.1.113883.6.163