Safety Management

Question 1

AR

Answer 1

Adverse Reaction, a specific term that indicates a direct relationship between an event and a product.

Question 2

adverse drug reaction (before market approval)

Answer 2

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.

Question 3

adverse drug reaction (after market approval)

Answer 3

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.

Question 4

Adverse Event

Answer 4

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.

Question 5

requirements of SAE

Answer 5

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

Question 6

associated (with the use of the product)

Answer 6

A reasonable possibility that the event could have been caused by the product.

Question 7

disability

Answer 7

A substantial disruption of a person’s ability to conduct normal life functions.

Question 8

Life-threatening adverse drug experience

Answer 8

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.

Question 9

Severity

Answer 9

refers to the intensity of the event and is generally indicated as mild, moderate, or severe

Question 10

Severity: Mild (based on signs and symptoms)

Answer 10

Minor signs/symptoms; no specific medical intervention required; asymptomatic laboratory findings only, radiographic findings only; marginal clinical relevance

Question 11

Severity: Moderate (based on signs and symptoms)

Answer 11

Requiring minimal, local, or non-invasive intervention only

Question 12

Severity: Severe (based on signs and symptoms)

Answer 12

Significant symptoms requiring hospitalization or invasive intervention

Question 13

Severity: Life-threatening or disabling (based on signs and symptoms)

Answer 13

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

Question 14

Severity: Fatal (based on signs and symptoms)

Answer 14

causing death

Question 15

Severity: Mild (based on effect on Usual Daily Activites)

Answer 15

An awareness of symptoms but easily tolerated

Question 16

Severity: Moderate (based on effect on Usual Daily Activites)

Answer 16

Symptoms interfere with normal daily activities

Question 17

Severity: Severe (based on effect on Usual Daily Activites)

Answer 17

Symptoms are incapacitating, with the inability to perform daily activities

Question 18

Causality

Answer 18

refers to the likelihood and extent that the investigational product being studied contributed to the development of an AE.

Question 19

When is expedited SAE reporting not required

Answer 19

event is serious but expected or not reasonably related to the investigational product

Question 20

SUSAR

Answer 20

Suspected Unexpected Serious Adverse Reactions (unexpected and associated with the investigational product)

Question 21

MedWatch

Answer 21

The program established by the FDA to gather AE information on marketed drugs, biologics, and medical devices.

Question 22

In ICH E6, what is the difference between an adverse event (AE) and adverse drug reaction (ADR)?

Answer 22

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.

Question 23

A study subject breaks his leg in a skating accident. Is this incident a Serious Adverse Event (SAE)?

Answer 23

Yes - if the subject stayed in hospital overnight or had serious complications.

Question 24

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?

Answer 24

This event would be an adverse event because the complaint is more frequent headaches since starting the study.