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Appendix III (B) GLOSSARY of TERMS
This section identifies the vocabulary sets referenced within the message, including both those
vocabularies already defined and those which are still under development.
In addition, there are many different terms used to describe basic concepts in healthcare
available from various national and international organisations. For the purposes of this
document, the following terms and definitions apply to facilitate conformance and
interoperability for regulatory reporting of adverse events for human pharmaceuticals.
Term Definition
Adverse Event Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and
which does not necessarily have a causal relationship with this
treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated
with the use of a medicinal (investigational) product, whether or
not related to the medicinal (investigational) product (see the
ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).[ICHE6(R1)]
Acknowledgement
Message (ICSRACK)
The acknowledgement message is an EDI Message with the
information on the result of the acknowledgement of receipt
procedure to acknowledge the receipt of one safety message and
the safety report(s) contained in the safety file.[EMA]
Adverse Drug Reaction
(ADR)
In the pre-approval clinical experience with a new medicinal
product or its new usages, particularly as the therapeutic dose(s)
cannot be established: all noxious and unintended responses to a
medicinal product related to any dose should be considered
adverse drug reactions. The phrase ‘responses to a medicinal
product’ means that a causal relationship between a medicinal
product and an adverse event is at least a reasonable possibility,
e.g. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug
which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy of
diseases or for modification of physiological function (See the
ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).[ICHE6(R1)]
Case An observation requiring investigation, and includes problems
that might or might not involve individual or groups of
investigative subjects.[HL7 Patient Safety]
ICH ICSR Implementation Guide 12 April 2013
-162-
Appendix III (B) GLOSSARY of TERMS
This section identifies the vocabulary sets referenced within the message, including both those
vocabularies already defined and those which are still under development.
In addition, there are many different terms used to describe basic concepts in healthcare
available from various national and international organisations. For the purposes of this
document, the following terms and definitions apply to facilitate conformance and
interoperability for regulatory reporting of adverse events for human pharmaceuticals.
Term Definition
Adverse Event Any untoward medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and
which does not necessarily have a causal relationship with this
treatment. An adverse event (AE) can therefore be any
unfavourable and unintended sign (including an abnormal
laboratory finding), symptom, or disease temporally associated
with the use of a medicinal (investigational) product, whether or
not related to the medicinal (investigational) product (see the
ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).[ICHE6(R1)]
Acknowledgement
Message (ICSRACK)
The acknowledgement message is an EDI Message with the
information on the result of the acknowledgement of receipt
procedure to acknowledge the receipt of one safety message and
the safety report(s) contained in the safety file.[EMA]
Adverse Drug Reaction
(ADR)
In the pre-approval clinical experience with a new medicinal
product or its new usages, particularly as the therapeutic dose(s)
cannot be established: all noxious and unintended responses to a
medicinal product related to any dose should be considered
adverse drug reactions. The phrase ‘responses to a medicinal
product’ means that a causal relationship between a medicinal
product and an adverse event is at least a reasonable possibility,
e.g. the relationship cannot be ruled out.
Regarding marketed medicinal products: a response to a drug
which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy of
diseases or for modification of physiological function (See the
ICH Guideline for Clinical Safety Data Management: Definitions
and Standards for Expedited Reporting).[ICHE6(R1)]
Case An observation requiring investigation, and includes problems
that might or might not involve individual or groups of
investigative subjects.[HL7 Patient Safety]