ACRP CCRC 500 Exam Questions WITH
COMPLETE SOLUTION
c) Is not necessarily causally related to drug Correct Answer: An adverse event is defined as one
which
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to drug
d) Is life threatening
d) a and b Correct Answer: 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
a) An adverse event Correct Answer: 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
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 Correct Answer: A response to a
medical product means (check all options 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
b) A noxious and unintended response to a drug Correct Answer: 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
d) a and b Correct Answer: For a drug that is in a Phase IV trial and 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
,e) All of the above Correct Answer: A serious adverse event is on which results in
a) Death or life threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) Congenital anomaly or birth defect
e) All of the above
b) An event where risk of death was evident at the time of the event Correct Answer: 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
d) a and b Correct Answer: 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 and intervention to prevent hospitalization
c) a only
d) a and b
d) May be considered serious and should be considered for expedited reporting Correct Answer:
A patient in a clinical I 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
d) All of the above Correct Answer: 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
b) Not mentioned in the investigator's brochure or relevant source document Correct Answer:
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
d) All of the above Correct Answer: 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
b) Serious and unexpected Correct Answer: 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
c) Submitted to the appropriate regulatory authority on an expedited basis Correct Answer:
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
a) Root cause analysis Correct Answer: 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
d) Causality Correct Answer: Adverse events of marketed drugs usually imply
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality
d) All of the above Correct Answer: Rapid communication of single case reports of serious
adverse events is merited if the information
a) Influences risk benefit assessment
b) Implies a change need in drug administration
c) A change in the conduct of the clinical investigation
d) All of the above
d) All of the above Correct Answer: 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
a) No later than 7 days after first knowledge of event
COMPLETE SOLUTION
c) Is not necessarily causally related to drug Correct Answer: An adverse event is defined as one
which
a) Results in hospitalization
b) Causes a disability
c) Is not necessarily causally related to drug
d) Is life threatening
d) a and b Correct Answer: 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
a) An adverse event Correct Answer: 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
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 Correct Answer: A response to a
medical product means (check all options 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
b) A noxious and unintended response to a drug Correct Answer: 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
d) a and b Correct Answer: For a drug that is in a Phase IV trial and 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
,e) All of the above Correct Answer: A serious adverse event is on which results in
a) Death or life threatening event
b) A hospitalization or prolongation of hospitalization
c) Persistent or significant disability
d) Congenital anomaly or birth defect
e) All of the above
b) An event where risk of death was evident at the time of the event Correct Answer: 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
d) a and b Correct Answer: 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 and intervention to prevent hospitalization
c) a only
d) a and b
d) May be considered serious and should be considered for expedited reporting Correct Answer:
A patient in a clinical I 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
d) All of the above Correct Answer: 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
b) Not mentioned in the investigator's brochure or relevant source document Correct Answer:
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
d) All of the above Correct Answer: 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
b) Serious and unexpected Correct Answer: 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
c) Submitted to the appropriate regulatory authority on an expedited basis Correct Answer:
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
a) Root cause analysis Correct Answer: 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
d) Causality Correct Answer: Adverse events of marketed drugs usually imply
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality
d) All of the above Correct Answer: Rapid communication of single case reports of serious
adverse events is merited if the information
a) Influences risk benefit assessment
b) Implies a change need in drug administration
c) A change in the conduct of the clinical investigation
d) All of the above
d) All of the above Correct Answer: 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
a) No later than 7 days after first knowledge of event
