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ICH ICSR Implementation Guide 12 April 2013
-14-
Subsequent sections of this IG provide explanatory text concerning the business context for
electronic ICSR messaging, including ICH documentation, and application to
pharmacovigilance transactions.
1.0 Purpose
The business objective of this ICH IG is to standardise the definition of the data elements used
in the electronic transmission of different types of ICSRs, regardless of source and destination.
This IG describes data elements for ICSRs for both the pre- and post-authorisation periods, and
addresses both adverse drug reaction reports and adverse event reports. The technical objective
of this IG is to assist reporters and recipients (including pharmaceutical companies, regulatory
authorities and non-commercial sponsors) in implementing systems to construct transmittable
ICSR messages. The representation of the ICSR follows an international standard that is
platform-, application-, and vendor-independent.
1.1 Scope
The representation of the ICSR in this IG, in its format and content, is made up of a large
number of data elements, allowing precise reporting of medical content to most business
partners, including regulatory authorities. For example, the data elements and their format are
suitable to describe several types of case reports including those without adverse events or
adverse reactions, such as medicinal product administration during pregnancy, overdose,
medication error, or potential lack of efficacy. Therefore, in order to maintain the integrity and
usability of the standard, requests for inclusion of additional local data should not be necessary
and should be avoided as much as possible. The scope of this IG for the ICH E2B (R3) ICSR
does not include the definition of database structures, the design of a paper report form, quality
control/quality assurance aspects, or technical security issues.
1.2 Business Case
Because of national and international agreements, rules, regulations, and the protection of
patient safety, there is a need to expedite the exchange of safety information (e.g. ICSRs):
from identified reporting sources to regulatory authorities and pharmaceutical companies
between regulatory authorities
between pharmaceutical companies and regulatory authorities
between pharmaceutical companies
from clinical investigators, via the sponsor of a clinical trial, to ethics committees or
from authorities to the World Health Organisation (WHO) Collaborating Centres for
International Drug Monitoring.
The exchange of safety information is based on paper-based formats (e.g. Yellow Cards,
CIOMS I forms, MedWatch forms, etc.) or electronic media (e.g. on-line access, tape, CD, etc).
Considering the large number of potential participants in a world-wide exchange of information,
there should be a standard format that is capable of accommodating direct database-to-database
transmission using standardised message transfers. Successful electronic transmission of
ICH ICSR Implementation Guide 12 April 2013
-14-
Subsequent sections of this IG provide explanatory text concerning the business context for
electronic ICSR messaging, including ICH documentation, and application to
pharmacovigilance transactions.
1.0 Purpose
The business objective of this ICH IG is to standardise the definition of the data elements used
in the electronic transmission of different types of ICSRs, regardless of source and destination.
This IG describes data elements for ICSRs for both the pre- and post-authorisation periods, and
addresses both adverse drug reaction reports and adverse event reports. The technical objective
of this IG is to assist reporters and recipients (including pharmaceutical companies, regulatory
authorities and non-commercial sponsors) in implementing systems to construct transmittable
ICSR messages. The representation of the ICSR follows an international standard that is
platform-, application-, and vendor-independent.
1.1 Scope
The representation of the ICSR in this IG, in its format and content, is made up of a large
number of data elements, allowing precise reporting of medical content to most business
partners, including regulatory authorities. For example, the data elements and their format are
suitable to describe several types of case reports including those without adverse events or
adverse reactions, such as medicinal product administration during pregnancy, overdose,
medication error, or potential lack of efficacy. Therefore, in order to maintain the integrity and
usability of the standard, requests for inclusion of additional local data should not be necessary
and should be avoided as much as possible. The scope of this IG for the ICH E2B (R3) ICSR
does not include the definition of database structures, the design of a paper report form, quality
control/quality assurance aspects, or technical security issues.
1.2 Business Case
Because of national and international agreements, rules, regulations, and the protection of
patient safety, there is a need to expedite the exchange of safety information (e.g. ICSRs):
from identified reporting sources to regulatory authorities and pharmaceutical companies
between regulatory authorities
between pharmaceutical companies and regulatory authorities
between pharmaceutical companies
from clinical investigators, via the sponsor of a clinical trial, to ethics committees or
from authorities to the World Health Organisation (WHO) Collaborating Centres for
International Drug Monitoring.
The exchange of safety information is based on paper-based formats (e.g. Yellow Cards,
CIOMS I forms, MedWatch forms, etc.) or electronic media (e.g. on-line access, tape, CD, etc).
Considering the large number of potential participants in a world-wide exchange of information,
there should be a standard format that is capable of accommodating direct database-to-database
transmission using standardised message transfers. Successful electronic transmission of