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Sender’s (case) Safety Report Unique Identifier (C.1.1)
Date of Creation(C.1.2)
Date Report Was First Received from Source (C.1.4)
Date of Most Recent Information for This Report (C.1.5)
Are Additional Documents Available? (C.1.6.1)
Does This Case Fulfil the Local Criteria for an Expedited Report? (C.1.7)
Information on Sender of Case Safety Report (C.3)
Seriousness Criteria at Event Level (E.i.3.2)
More Information Available (F.r.7)
Assessment of Relatedness of Drug to Reaction(s)/ Event(s) (repeat as necessary)
(G.k.9.i.2.r)
Sender's Diagnosis (repeat as necessary) (H.3.r)
Sender's Comments (H.4) and
English translation of the free text data elements in the ICSRs.
In addition to these data elements, it is also possible to update MedDRA coded data elements
with the most recent version of MedDRA.
There could be situations in which more than one ICSR shares the same ‘Worldwide Unique
Case Identification Number’ (C.1.8.1), or due to sequential updates to information in the same
case, more than one ICSR could share the same ‘Date of Most Recent Information’ (C.1.5).For
these situations, ‘Date of Creation’ (C.1.2) should be used to identify the most recent version of
the case.
3.3.5 Notes on Format of Data Elements
E2B (R3) data elements have a hierarchical tree structure. It consists of two major sections A
and B, where A contains administrative and identification information, and B contains
information on the case. The subsidiary sections are categorised by the nature of the data, and
are:
Section A
o C.1 -Identification of the Case Safety Report
o C.2- Primary Source(s) of Information
o C.3 -Information on Sender of Case Safety Report
o C.4 -Literature Reference(s)
o C.5 -Study Identification.
Section B
o D -Patient Characteristics
o E -Reaction(s)/ Event(s)
ICH ICSR Implementation Guide 12 April 2013
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Sender’s (case) Safety Report Unique Identifier (C.1.1)
Date of Creation(C.1.2)
Date Report Was First Received from Source (C.1.4)
Date of Most Recent Information for This Report (C.1.5)
Are Additional Documents Available? (C.1.6.1)
Does This Case Fulfil the Local Criteria for an Expedited Report? (C.1.7)
Information on Sender of Case Safety Report (C.3)
Seriousness Criteria at Event Level (E.i.3.2)
More Information Available (F.r.7)
Assessment of Relatedness of Drug to Reaction(s)/ Event(s) (repeat as necessary)
(G.k.9.i.2.r)
Sender's Diagnosis (repeat as necessary) (H.3.r)
Sender's Comments (H.4) and
English translation of the free text data elements in the ICSRs.
In addition to these data elements, it is also possible to update MedDRA coded data elements
with the most recent version of MedDRA.
There could be situations in which more than one ICSR shares the same ‘Worldwide Unique
Case Identification Number’ (C.1.8.1), or due to sequential updates to information in the same
case, more than one ICSR could share the same ‘Date of Most Recent Information’ (C.1.5).For
these situations, ‘Date of Creation’ (C.1.2) should be used to identify the most recent version of
the case.
3.3.5 Notes on Format of Data Elements
E2B (R3) data elements have a hierarchical tree structure. It consists of two major sections A
and B, where A contains administrative and identification information, and B contains
information on the case. The subsidiary sections are categorised by the nature of the data, and
are:
Section A
o C.1 -Identification of the Case Safety Report
o C.2- Primary Source(s) of Information
o C.3 -Information on Sender of Case Safety Report
o C.4 -Literature Reference(s)
o C.5 -Study Identification.
Section B
o D -Patient Characteristics
o E -Reaction(s)/ Event(s)