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8/9/2019 Definitions ADR (2).pdf
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Definitions
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.
Unexpected
adverse event
an event when the specificity or severity is not consistent with the investigator
brochure or general investigative plan
Related adverse
event adverse event
when there is a reasonable possibility that the adverse event is caused by the
research activity (drug/device/procedure)
Definitely Related
adverse event
An adverse event that has a timely relationship to the administration of the
investigational drug/study procedure and follows a known pattern of response
for which no alternative cause is present.
Probably related
adverse event
AE has a timely relationship to the administration of the investigational
drug/study procedure and follows a known pattern of response, but for which a
potential alternative cause may be present.
Possibly related
adverse event
AE has a timely relationship to the administration of the investigational
drug/study procedure, follows no known pattern of response, but a potential
alternative cause does not exist
Unrelated
adverse event
There is evidence that the AE is definitely related to a cause other than the
investigational drug/study procedure; in general, no timely relationship to the
administration of the drug/procedure exists, or if so, the event does not follow a
pattern of response and an alternative cause is present.
Adverse Drug
reactions
All noxious and unintended responses to a medicinal product related to any
dose should be considered.
8/9/2019 Definitions ADR (2).pdf
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Mild adverse
events
Awareness of signs or symptoms, but easily tolerated; are of minor irritant
type; causing no loss of time from normal activities; symptoms would not
require medication or a medical evaluation; signs and symptoms are transient.
Moderate
adverse events
Discomfort severe enough to cause interference with usual activities; persistent
or requiring treatment.
Severe adverse
event
The term "severe" is often used to describe the intensity (severity) of a specific
event (as in mild, moderate, or severe); the event itself, however, may be of
relatively minor medical significance.
Clinical Study Bioavailability/Bioequivalence study or Phase 1 study
Serious adverse
event (SAE):
Any untoward medical occurrence in a patient or clinical investigation in a
subject administered a pharmaceutical product with any dose that:
Results in death, is life-threatening, requires in-patient hospitalization or
prolongation of existing hospitalization, results in persistent or significant
disability/ incapacity, or is a congenital anomaly/birth defect. Important
medical events that may not result in death, be life-threatening, or require
hospitalization may be considered a serious adverse experience when, based
upon appropriate medical judgment, they may jeopardize the patient or subject
and may require medical or surgical intervention to prevent one of the
outcomes listed above.
E2A:Clinical safety data management; definitions and standards for expedited data reportingE2B: ICH; Guidance on data elements for transmission of individual case safety reportsE2C: Clinical safety data management; periodic safety update reports for marketed drugsSchedule Y: Requirements and guidelines for permission to import and/or manufacture new
drugs for sale or to undertake clinical trialsICH Harmonised tripartite guideline for Good Clinical Practice E6 recommended for adoption atstep 4 of the ICH process on 01 may 1996 by the ICH Steering Committee (including the poststep 4 corrections agreed by this Steering Committee on 10 June 1996).
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