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important to understand if a data element is null because it is not applicable or because it is
unknown or because it is ‘protected’ by privacy legislation. In those cases, provisions for
expressing a null value are included in the message for a data element to indicate the absence of
data and reason.
Furthermore, in addition to the minimum information required for an ICSR report (See Section
3.3.1) certain specific administrative information should be provided to properly process the
report:
Sender’s (case) Safety Report Unique Identifier (C.1.1)
Type of Report (C.1.3)
Date of Most Recent Information for This Report (C.1.5)
Dose This Case Fulfil the Local Criteria for an Expedited Report? (C.1.7)
Worldwide Unique Case Identification (C.1.8)
Reporter’s Country Code (C.2.r.3)
Sender’s Organisation (C.3.2) and
When type of report=‘Report from study’, Study Type Where Reaction(s) /Event(s)Were
Observed (C.5.4).
3.3.3 General Principles
While complete information is desirable, a minimum set of information is always required for
an ICSR to be valid. This applies to all types of ICSRs including initial case reports, follow-up
information, and cases to be amended or nullified.
All the information available should be reported in fully structured format using the relevant
E2B(R3) data elements and applicable standard terminologies. Those terminologies include
ISO (country codes, gender codes and language codes), MedDRA (e.g. medical history,
indication, and reaction /event), UCUM (units of measurement), and ICH M5 (IDMP, see
Section 3.2.1.1 for details). Please refer to each standard for further information.
Although the exchange of other unstructured data (e.g. published articles, full clinical records,
X-Ray images, etc.) is outside the scope of this IG, the technical solution to transmit
attachments is provided in Section 3.5.
3.3.4 Retransmission of cases
Based on regional reporting obligations and business arrangements in pharmacovigilance, an
ICSR may be re-transmitted several times between different senders and receivers. During this
re-transmission process, medical information ‘received’ on the case should not be omitted or
changed during the retransmission when no new information on the case is available to the re-
transmitting sender.
There are certain exceptions and the following data elements might be updated:
ICH ICSR Implementation Guide 12 April 2013
-33-
important to understand if a data element is null because it is not applicable or because it is
unknown or because it is ‘protected’ by privacy legislation. In those cases, provisions for
expressing a null value are included in the message for a data element to indicate the absence of
data and reason.
Furthermore, in addition to the minimum information required for an ICSR report (See Section
3.3.1) certain specific administrative information should be provided to properly process the
report:
Sender’s (case) Safety Report Unique Identifier (C.1.1)
Type of Report (C.1.3)
Date of Most Recent Information for This Report (C.1.5)
Dose This Case Fulfil the Local Criteria for an Expedited Report? (C.1.7)
Worldwide Unique Case Identification (C.1.8)
Reporter’s Country Code (C.2.r.3)
Sender’s Organisation (C.3.2) and
When type of report=‘Report from study’, Study Type Where Reaction(s) /Event(s)Were
Observed (C.5.4).
3.3.3 General Principles
While complete information is desirable, a minimum set of information is always required for
an ICSR to be valid. This applies to all types of ICSRs including initial case reports, follow-up
information, and cases to be amended or nullified.
All the information available should be reported in fully structured format using the relevant
E2B(R3) data elements and applicable standard terminologies. Those terminologies include
ISO (country codes, gender codes and language codes), MedDRA (e.g. medical history,
indication, and reaction /event), UCUM (units of measurement), and ICH M5 (IDMP, see
Section 3.2.1.1 for details). Please refer to each standard for further information.
Although the exchange of other unstructured data (e.g. published articles, full clinical records,
X-Ray images, etc.) is outside the scope of this IG, the technical solution to transmit
attachments is provided in Section 3.5.
3.3.4 Retransmission of cases
Based on regional reporting obligations and business arrangements in pharmacovigilance, an
ICSR may be re-transmitted several times between different senders and receivers. During this
re-transmission process, medical information ‘received’ on the case should not be omitted or
changed during the retransmission when no new information on the case is available to the re-
transmitting sender.
There are certain exceptions and the following data elements might be updated: