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ICH ICSR Implementation Guide 12 April 2013
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Table5: E2B (R3) data elements and ICSR message Namespace OIDs
Element id Element Name ICH OID
N.1.2 Batch Number 2.16.840.1.113883.3.989.2.1.3.22
N.1.3 Batch Sender Identifier 2.16.840.1.113883.3.989.2.1.3.13
N.1.4 Batch Receiver Identifier 2.16.840.1.113883.3.989.2.1.3.14
N.2.r.2 Message Sender Identifier 2.16.840.1.113883.3.989.2.1.3.11
N.2.r.3 Message Receiver Identifier 2.16.840.1.113883.3.989.2.1.3.12
C.1.1 Sender’s (case) Safety Report
Unique Identifier 2.16.840.1.113883.3.989.2.1.3.1
C.1.8.1 Worldwide Unique Case
Identification Number 2.16.840.1.113883.3.989.2.1.3.2
C.1.9.1.r.1,
C.1.9.1.r.2
Source(s) of Case Identifier
(repeated as necessary) and Case
Identifier(s)
2.16.840.1.113883.3.989.2.1.3.3
C.5.1.r.1 Study Registration Number 2.16.840.1.113883.3.989.2.1.3.6
C.5.3 Sponsor Study Number 2.16.840.1.113883.3.989.2.1.3.5
D.1.1.1 Patient Medical Record
Number(s)(GP) 2.16.840.1.113883.3.989.2.1.3.7
D.1.1.2 Patient Medical Record
Number(s)(Specialist) 2.16.840.1.113883.3.989.2.1.3.8
D.1.1.3 Patient Medical Record
Number(s)(Hospital) 2.16.840.1.113883.3.989.2.1.3.9
D.1.1.4 Patient Medical Record Number(s)
(Investigation) 2.16.840.1.113883.3.989.2.1.3.10
G.k.3.1 Authorisation /Application Number 2.16.840.1.113883.3.989.2.1.3.4
Table6: E2B (R3) data elements and Ack message Namespace OIDs
Element id Element Name ICH OID
ACK.M.2 Acknowledgement Batch Sender
Identifier 2.16.840.1.113883.3.989.2.1.3.17
ACK.M.3 Acknowledgement Batch Receiver
Identifier 2.16.840.1.113883.3.989.2.1.3.18
ACK.B.r.3 ICSR Message ACK Receiver 2.16.840.1.113883.3.989.2.1.3.16
ACK.B.r.4 ICSR Message ACK Sender 2.16.840.1.113883.3.989.2.1.3.15
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