ACRP CRC Exam Question and Answers Already Passed
An adverse event is defined as one which:
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to the drug
d) Is life threatening - Answers C) Is not necessarily causally related to drug
An adverse event is one which:
a) Is an unfavorable and unintended sign, symptom, or disease
b) Is one that is temporally associated with drug regardless of whether it is related or not
c) A Only
d) A and B - Answers d) A and B
A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is
most likely classified as:
a) an adverse event
b) an adverse drug reaction
c) an unexpected adverse drug reaction
d) a serious adverse event - Answers A) An adverse event
A response to a medical product means (Select all that Apply):
a) A causal relationship between drug and adverse event is established
b) A causal relationship between drug and adverse event is a reasonable possibility
c) The relationship of the event to drug cannot be ruled out
d) An event that requires active medical intervention - Answers b and c. B) A causal relationship
between drug and adverse event is a reasonable possibility and C) The relationship of the event
to drug cannot be ruled out.
An adverse drug reaction is one which:
a) Results in death or hospitalization
b) A noxious and unintended response to a drug
,c) Occurs frequently and with greater severity than usual.
d) Likely occurs at normal doses of the drug - Answers B) A noxious and unintended response
to a drug
For a drug that is in a Phase IV trial an adverse drug reaction is one which:
a) Is noxious and unintended
b) Occurs at normal doses used for prophylaxis
c) A only
d) A and B - Answers d) A and B
A serious adverse event is one which results in:
a) Death or life-threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) All of the Above - Answers d) All of the above
The term, life-threatening, in a serious adverse event refers to:
a) An event which required hospitalization
b) An event where risk of death was evident at the time of the event
c) An event that required treatment in an emergency room
d) An event which might have caused a death if left untreated - Answers b) An event where risk
of death was evident at the time of the event.
An event may be classified as serious if it:
a) Not immediately life threatening, but may jeopardize the patient
b) Not immediately life threatening, but may require an intervention to prevent hospitalization
c) A only
d) A and B - Answers d) A and B
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The event
would be:
a) not reportable because it occurred in a home setting
,b) An adverse event which does not require reporting
c) An unexpected adverse event which does not require expedited reporting
d) May be considered serious and should be considered for expedited reporting - Answers d)
May be considered serious and should be considered for expedited reporting
Events which may be classified as serious even though they do not result in hospitalization
include:
a) Allergic bronchospasm
b) Blood dyscrasias
c) Convulsions
d) All of the above - Answers d) All of the above
An unexpected adverse reaction is one which is:
a) Not expected by the investigator
b) Not mentioned in the Investigator's brochure or relevant source document
c) Classified as such by the IRB
d) Classified as such by the sponsor's medical safety officer. - Answers b) Not mentioned in the
Investigator's brochure or relevant source document.
Which of the following is an unexpected adverse event?
a) A report which adds significant information to an already documented serious adverse event.
b) A report of interstitial nephritis in a patient with acute renal failure
c) A report of fulminant hepatitis in patient with an initial report of hepatitis.
d) All of the above - Answers d) All of the above
For expedited reporting an event must be:
a) Serious
b) Serious and Unexpected
c) Only temporally associated with drug administration
d) Causally related to drug administration. - Answers b) Serious and Unexpected
According to ICH serious unexpected reaction to a drug should be:
, a) Submitted to the appropriate regulatory authority within one week.
b) Submitted to the appropriate regulatory authority within 15 days.
c) Submitted to the appropriate regulatory authority on an expedited basis.
d) Submitted promptly to the IRB - Answers c) Submitted to the appropriate regulatory authority
on an expedited basis.
Clinical investigation of adverse events in clinical trials requires:
a) Root cause analysis
b) Complete medical records review
c) Investigation of potential protocol deviations
d) Causality assessment - Answers a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - Answers d) Causality
Rapid communication of single case reports of serious adverse events is merited if the
information:
a) Influences risk benefit assessment
b) Implies a change needed in drug administration
c) A change in the conduct of the clinical investigation
d) All of the above - Answers d) All of the above
Expedited reporting of serious adverse events may be considered if:
a) There is an increased rate of occurrence in the serious adverse drug reaction.
b) A lack of efficacy is evident in treating a life-threatening disease
c) A new safety consideration is evident from a new animal study.
d) All of the above - Answers d) All of the above.
An adverse event is defined as one which:
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to the drug
d) Is life threatening - Answers C) Is not necessarily causally related to drug
An adverse event is one which:
a) Is an unfavorable and unintended sign, symptom, or disease
b) Is one that is temporally associated with drug regardless of whether it is related or not
c) A Only
d) A and B - Answers d) A and B
A subject in an arthritis clinical trial develops a severe cold and flu like symptoms. This event is
most likely classified as:
a) an adverse event
b) an adverse drug reaction
c) an unexpected adverse drug reaction
d) a serious adverse event - Answers A) An adverse event
A response to a medical product means (Select all that Apply):
a) A causal relationship between drug and adverse event is established
b) A causal relationship between drug and adverse event is a reasonable possibility
c) The relationship of the event to drug cannot be ruled out
d) An event that requires active medical intervention - Answers b and c. B) A causal relationship
between drug and adverse event is a reasonable possibility and C) The relationship of the event
to drug cannot be ruled out.
An adverse drug reaction is one which:
a) Results in death or hospitalization
b) A noxious and unintended response to a drug
,c) Occurs frequently and with greater severity than usual.
d) Likely occurs at normal doses of the drug - Answers B) A noxious and unintended response
to a drug
For a drug that is in a Phase IV trial an adverse drug reaction is one which:
a) Is noxious and unintended
b) Occurs at normal doses used for prophylaxis
c) A only
d) A and B - Answers d) A and B
A serious adverse event is one which results in:
a) Death or life-threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) All of the Above - Answers d) All of the above
The term, life-threatening, in a serious adverse event refers to:
a) An event which required hospitalization
b) An event where risk of death was evident at the time of the event
c) An event that required treatment in an emergency room
d) An event which might have caused a death if left untreated - Answers b) An event where risk
of death was evident at the time of the event.
An event may be classified as serious if it:
a) Not immediately life threatening, but may jeopardize the patient
b) Not immediately life threatening, but may require an intervention to prevent hospitalization
c) A only
d) A and B - Answers d) A and B
A patient in a clinical trial for joint pain experiences a bronchospasm while at home. The event
would be:
a) not reportable because it occurred in a home setting
,b) An adverse event which does not require reporting
c) An unexpected adverse event which does not require expedited reporting
d) May be considered serious and should be considered for expedited reporting - Answers d)
May be considered serious and should be considered for expedited reporting
Events which may be classified as serious even though they do not result in hospitalization
include:
a) Allergic bronchospasm
b) Blood dyscrasias
c) Convulsions
d) All of the above - Answers d) All of the above
An unexpected adverse reaction is one which is:
a) Not expected by the investigator
b) Not mentioned in the Investigator's brochure or relevant source document
c) Classified as such by the IRB
d) Classified as such by the sponsor's medical safety officer. - Answers b) Not mentioned in the
Investigator's brochure or relevant source document.
Which of the following is an unexpected adverse event?
a) A report which adds significant information to an already documented serious adverse event.
b) A report of interstitial nephritis in a patient with acute renal failure
c) A report of fulminant hepatitis in patient with an initial report of hepatitis.
d) All of the above - Answers d) All of the above
For expedited reporting an event must be:
a) Serious
b) Serious and Unexpected
c) Only temporally associated with drug administration
d) Causally related to drug administration. - Answers b) Serious and Unexpected
According to ICH serious unexpected reaction to a drug should be:
, a) Submitted to the appropriate regulatory authority within one week.
b) Submitted to the appropriate regulatory authority within 15 days.
c) Submitted to the appropriate regulatory authority on an expedited basis.
d) Submitted promptly to the IRB - Answers c) Submitted to the appropriate regulatory authority
on an expedited basis.
Clinical investigation of adverse events in clinical trials requires:
a) Root cause analysis
b) Complete medical records review
c) Investigation of potential protocol deviations
d) Causality assessment - Answers a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - Answers d) Causality
Rapid communication of single case reports of serious adverse events is merited if the
information:
a) Influences risk benefit assessment
b) Implies a change needed in drug administration
c) A change in the conduct of the clinical investigation
d) All of the above - Answers d) All of the above
Expedited reporting of serious adverse events may be considered if:
a) There is an increased rate of occurrence in the serious adverse drug reaction.
b) A lack of efficacy is evident in treating a life-threatening disease
c) A new safety consideration is evident from a new animal study.
d) All of the above - Answers d) All of the above.
