Safety Management Flashcards
AR
Adverse Reaction, a specific term that indicates a direct relationship between an event and a product.
adverse drug reaction (before market approval)
Any noxious and unintended response to a medicinal product related to any dose and the causal relationship between the medicinal product and an adverse reaction (AR) is at least a reasonable possibility.
adverse drug reaction (after market approval)
Any noxious and unintended response to a product that occurs at doses normally used in man to prevent, diagnose, or treat disease or to modify physiological function.
Adverse Event
Any untoward medical occurrence in a patient or clinical investigation subject given a pharmaceutical product whether or not there is a causal relationship with this treatment.
requirements of SAE
results in death; is life-threatening; requires in patient hospitalization or prolongs existing hospitalization; results in persistent or significant disability, is a congenital anomaly/birth defect
associated (with the use of the product)
A reasonable possibility that the event could have been caused by the product.
disability
A substantial disruption of a person’s ability to conduct normal life functions.
Life-threatening adverse drug experience
Any adverse drug experience that places the subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, that is, it does not include reactions that, had they occurred in more severe forms, might have caused death.
Severity
refers to the intensity of the event and is generally indicated as mild, moderate, or severe
Severity: Mild (based on signs and symptoms)
Minor signs/symptoms; no specific medical intervention required; asymptomatic laboratory findings only, radiographic findings only; marginal clinical relevance
Severity: Moderate (based on signs and symptoms)
Requiring minimal, local, or non-invasive intervention only
Severity: Severe (based on signs and symptoms)
Significant symptoms requiring hospitalization or invasive intervention
Severity: Life-threatening or disabling (based on signs and symptoms)
Complicated by acute, life-threatening metabolic, or cardiovascular complications (such as circulatory failure, hemorrhage, sepsis); life-threatening physiological consequences; or need for intensive care or emergent invasive procedure
Severity: Fatal (based on signs and symptoms)
causing death
Severity: Mild (based on effect on Usual Daily Activites)
An awareness of symptoms but easily tolerated
Severity: Moderate (based on effect on Usual Daily Activites)
Symptoms interfere with normal daily activities
Severity: Severe (based on effect on Usual Daily Activites)
Symptoms are incapacitating, with the inability to perform daily activities
Causality
refers to the likelihood and extent that the investigational product being studied contributed to the development of an AE.
When is expedited SAE reporting not required
event is serious but expected or not reasonably related to the investigational product
SUSAR
Suspected Unexpected Serious Adverse Reactions (unexpected and associated with the investigational product)
MedWatch
The program established by the FDA to gather AE information on marketed drugs, biologics, and medical devices.
In ICH E6, what is the difference between an adverse event (AE) and adverse drug reaction (ADR)?
An adverse drug reaction is a response to the investigational product and an adverse event may or may not be a response to the investigational product.
A study subject breaks his leg in a skating accident. Is this incident a Serious Adverse Event (SAE)?
Yes - if the subject stayed in hospital overnight or had serious complications.
A study subject reports that he has been having headaches for years but they seem to have become more frequent since starting the study. The investigator believes this is not related to the study medication. How would a clinical research coordinator document this event?
This event would be an adverse event because the complaint is more frequent headaches since starting the study.
