ACRP CCRA Exam | Questions with 100% Correct
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Terms in this set (14)
Adverse drug reaction (ADR) refers to any harmful and unintended response to a
medicinal product. During pre-approval clinical
trials, all adverse reactions related to any dose are
considered ADRs, especially since the therapeutic
doses may not yet be established. The term
"responses to a medicinal product" suggests a
reasonable possibility of a causal link between the
drug and the adverse event, which cannot be ruled
out. For marketed drugs, an ADR is a noxious and
unintended reaction occurring at doses commonly
used for preventing, diagnosing, or treating
diseases, or for altering physiological functions, as
outlined in the ICH Guideline for Clinical Safety
Data Management.
Adverse event 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)
Answers | Verified | Latest Update 2026/2027
Save
Terms in this set (14)
Adverse drug reaction (ADR) refers to any harmful and unintended response to a
medicinal product. During pre-approval clinical
trials, all adverse reactions related to any dose are
considered ADRs, especially since the therapeutic
doses may not yet be established. The term
"responses to a medicinal product" suggests a
reasonable possibility of a causal link between the
drug and the adverse event, which cannot be ruled
out. For marketed drugs, an ADR is a noxious and
unintended reaction occurring at doses commonly
used for preventing, diagnosing, or treating
diseases, or for altering physiological functions, as
outlined in the ICH Guideline for Clinical Safety
Data Management.
Adverse event 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)
