ICH E2A Flashcards
Adverse Event (or Adverse Experience)
An untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a casual relationship with this treatment.
An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product.
T or F?
True
Adverse Drug Reaction
(pre-approval clinical experience)
All noxious and unintended responses to medicinal products related to any dose should be considered adverse drug reactions.
“Responses to medicinal products” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out
Adverse Drug Reaction
(marketed medicinal products/ post-marketing setting)
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 disease or for modification of physiological function.
“side effect”
An old term that has been use din the past, usually to describe negative effects, but also positive effects. It is recommended that the term no longer be used and particularly should not be regarded as synonymous with adverse event or adverse reaction.
Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g. Investigator’s Brochure for an unapproved investigational medicinal product)
severe vs serious
severe - describes the intensity (severity) of a specific event, the event itself may be of relatively minor medical significance
serious - based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient’s life or functioning.
Seriousness (not severity) serves as a guide for defining regulatory reporting obligations.
Serious Adverse Event (Experience) or Reaction
any untoward medical occurrence that any dose:
results in death
is life-threatening
requires inpatient hospitalization or prolongation of existing hospitalizations
results in persistent or significant disability/incapacity
is a congenital anomaly/birth defect
life threatening
in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe.
Not appropriate for expedited reporting
- serious but expected.
- not related to study product, whether expected or not
- non0serious adverse reactions, whether expected or not
reasonable causal relationship
facts (evidence) or arguments to suggest a causal relationship
Reporting Timeframes for Fatal of Life-Threatening Unexpected ADR’s
regulatory agencies should be notified as soon as possible but no later than 7 calendar days after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days
Reporting Time Frame for All Other Serious, Unexpected ADRs
as soon as possible but no later than 15 calendar days after first knowledge by the sponsor
Breaking the blind
when a serious adverse reaction is judged reportable on an expedited basis, it is recommended that the blind be broken only for that specific patient by the sponsor even if the investigator has not broken the blind
What is the timeline for reporting serious, Fatal or Life-Threatening Unexpected ADRs ?
(SPONSOR TO FDA)
7 calendar days from the day it became known for the first time
