ACRP CRC EXAM QUESTION BANK QUESTIONS AND ANSWERS
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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT
ANSWER✅✅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 - CORRECT ANSWER✅✅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. - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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. - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - CORRECT ANSWER✅✅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
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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT
ANSWER✅✅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 - CORRECT ANSWER✅✅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. - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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. - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅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 - CORRECT ANSWER✅✅a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - CORRECT ANSWER✅✅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
