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E.i.2.1b Reaction /Event (MedDRA code)
User Guidance This data element captures the MedDRA LLT most closely corresponding
to the reaction/event as reported by the primary source. In the exceptional
circumstance when a MedDRA term cannot be found, the sender should
use clinical judgment to complete this item with the best MedDRA
approximation (See MedDRA Term Selection: Points to Consider).
Conformance Required
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
E.i.3.1 Term Highlighted by the Reporter
User Guidance A highlighted term is a reaction/event that the primary source indicated
was a major concern or reason for reporting the case. If the information is
not explicitly provided by the initial reporter the term should not be
considered a highlighted term. This data element should be populated only
if the medical concept conveyed in E.i.1 is consistent with the reason why
the reporter contacted the sender. For example, this data element can be
used to indicate the specific diagnosis that was identified by the reporter.
Suppose the reporter specifies flu-like syndrome comprising of fever,
chills, sneezing, myalgia and headache, then flu-like syndrome is the
highlighted term. If only one event is cited in a case report, this one is by
implication considered highlighted by the reporter.
It is assumed that the event seriousness is provided by the reporter
otherwise, it is assessed by the sender.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.10
Value Allowed 1 =Yes, highlighted by the reporter, NOT serious
2 =No, not highlighted by the reporter, NOT serious
3 =Yes, highlighted by the reporter, SERIOUS
4 =No, not highlighted by the reporter, SERIOUS
Business Rule(s)
See E.i.3.2 for the ‘seriousness’ assessment of the highlighted term.
E.i.3.2 Seriousness Criteria at Event Level
The seriousness criteria of the reaction/event should be based on the definitions provided in the
ICH E2A and E2D guidelines. More than one seriousness criteria can be chosen. If the event is
not serious, all of these data elements should be left blank. It is assumed that the event
seriousness is provided by the reporter otherwise, it is assessed by the sender.
In cases of foetal demise such as miscarriage, (where the ICSR should be prepared only for the
parent), the seriousness criterion is ‘Other medically important condition’. Furthermore,
depending if the parent experienced complications, the seriousness criterion could also include
‘life-threatening’ and/or ‘hospitalisation’.
ICH ICSR Implementation Guide 12 April 2013
-103-
E.i.2.1b Reaction /Event (MedDRA code)
User Guidance This data element captures the MedDRA LLT most closely corresponding
to the reaction/event as reported by the primary source. In the exceptional
circumstance when a MedDRA term cannot be found, the sender should
use clinical judgment to complete this item with the best MedDRA
approximation (See MedDRA Term Selection: Points to Consider).
Conformance Required
Data Type 8N
OID 2.16.840.1.113883.6.163
Value Allowed Numeric
Business Rule(s)
E.i.3.1 Term Highlighted by the Reporter
User Guidance A highlighted term is a reaction/event that the primary source indicated
was a major concern or reason for reporting the case. If the information is
not explicitly provided by the initial reporter the term should not be
considered a highlighted term. This data element should be populated only
if the medical concept conveyed in E.i.1 is consistent with the reason why
the reporter contacted the sender. For example, this data element can be
used to indicate the specific diagnosis that was identified by the reporter.
Suppose the reporter specifies flu-like syndrome comprising of fever,
chills, sneezing, myalgia and headache, then flu-like syndrome is the
highlighted term. If only one event is cited in a case report, this one is by
implication considered highlighted by the reporter.
It is assumed that the event seriousness is provided by the reporter
otherwise, it is assessed by the sender.
Conformance Optional
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.10
Value Allowed 1 =Yes, highlighted by the reporter, NOT serious
2 =No, not highlighted by the reporter, NOT serious
3 =Yes, highlighted by the reporter, SERIOUS
4 =No, not highlighted by the reporter, SERIOUS
Business Rule(s)
See E.i.3.2 for the ‘seriousness’ assessment of the highlighted term.
E.i.3.2 Seriousness Criteria at Event Level
The seriousness criteria of the reaction/event should be based on the definitions provided in the
ICH E2A and E2D guidelines. More than one seriousness criteria can be chosen. If the event is
not serious, all of these data elements should be left blank. It is assumed that the event
seriousness is provided by the reporter otherwise, it is assessed by the sender.
In cases of foetal demise such as miscarriage, (where the ICSR should be prepared only for the
parent), the seriousness criterion is ‘Other medically important condition’. Furthermore,
depending if the parent experienced complications, the seriousness criterion could also include
‘life-threatening’ and/or ‘hospitalisation’.