ACRP Practice Exam 2024 Questions and
Answers
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 - 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 - 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 - 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. - 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 - 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. - b) Serious and Unexpected
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - b) An event where risk
of death was evident at the time of the event.
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 - 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 - a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - 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 - 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 - d) All of the above.
Fatal or life-threatening and unexpected adverse drug reactions in clinical investigations
should be reported to the regulatory agencies (select all that apply):
, a) No later than 7 days after first knowledge of event.
b) No later than 15 days after first knowledge of event.
c) By filing a complete report within 8 additional days of the initial notification
d) By filing a complete report within 15 additional days of the initial notification. - A and
C.
A) No later than 7 days after first knowledge of event.
C) By filing a complete report within 8 additional days of the initial notification.
Serious adverse drug reactions must be filed with regulatory agencies:
a) As soon as possible, but not later than 8 days of first knowledge.
b) As soon as possible, but not later than 10 days of first knowledge.
c) As soon as possible, but not later then 15 days of first knowledge.
d) As soon as possible, but not later than 1 month of first knowledge. - c) As soon as
possible, but not later than 15 days of first knowledge.
In ascertaining the basis for a serious adverse drug reaction in a randomized trial:
a) Care should be taken not to break the blind for the patient.
b) Care should be taken to break the blind only for the single patient involved.
c) The blind for the group of patients being treated at the site should be broken.
d) The blind for the single patient should be broken only if the sponsor approves. - b)
Care should be taken to break the blind only for the single patient involved
Breaking the blind for a single patient in randomized clinical trial:
a) Has negative implications for data integrity at the site level.
b) Has little or no significant implication for the investigation or financial data analysis.
c) May compromise drug approval because of implications for financial data analysis.
d) Provides no significant information regarding the safety of the patient. - b) Has little or
no significant implication for the investigation or financial data analysis.
Adverse drug reactions in the control group should be reported to:
a) The other manufacturer
b) Appropriate regulatory agency
c) A only
d) A and B - d) A and B.
A) The other manufacturer
B) Appropriate regulatory agency
An adverse reaction occurs in patients after the study has been completed. The
appropriate action on the part of the investigatorinclude:
a) Report the event to the sponsor.
b) Consider the event for reporting as though it was a study report.
c) Conduct causality assessment and determination of expectedness prior to expedited
reporting.
d) All of the above - d) All of the above
New safety information regarding a study drug should be updated by the sponsor by:
Answers
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 - 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 - 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 - 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. - 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 - 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. - b) Serious and Unexpected
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - b) An event where risk
of death was evident at the time of the event.
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 - 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 - a) Root cause analysis
Adverse events of marketed drugs usually imply:
a) Multi-drug interactions
b) Unreliable subjective measures
c) Psychosomatic factors
d) Causality - 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 - 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 - d) All of the above.
Fatal or life-threatening and unexpected adverse drug reactions in clinical investigations
should be reported to the regulatory agencies (select all that apply):
, a) No later than 7 days after first knowledge of event.
b) No later than 15 days after first knowledge of event.
c) By filing a complete report within 8 additional days of the initial notification
d) By filing a complete report within 15 additional days of the initial notification. - A and
C.
A) No later than 7 days after first knowledge of event.
C) By filing a complete report within 8 additional days of the initial notification.
Serious adverse drug reactions must be filed with regulatory agencies:
a) As soon as possible, but not later than 8 days of first knowledge.
b) As soon as possible, but not later than 10 days of first knowledge.
c) As soon as possible, but not later then 15 days of first knowledge.
d) As soon as possible, but not later than 1 month of first knowledge. - c) As soon as
possible, but not later than 15 days of first knowledge.
In ascertaining the basis for a serious adverse drug reaction in a randomized trial:
a) Care should be taken not to break the blind for the patient.
b) Care should be taken to break the blind only for the single patient involved.
c) The blind for the group of patients being treated at the site should be broken.
d) The blind for the single patient should be broken only if the sponsor approves. - b)
Care should be taken to break the blind only for the single patient involved
Breaking the blind for a single patient in randomized clinical trial:
a) Has negative implications for data integrity at the site level.
b) Has little or no significant implication for the investigation or financial data analysis.
c) May compromise drug approval because of implications for financial data analysis.
d) Provides no significant information regarding the safety of the patient. - b) Has little or
no significant implication for the investigation or financial data analysis.
Adverse drug reactions in the control group should be reported to:
a) The other manufacturer
b) Appropriate regulatory agency
c) A only
d) A and B - d) A and B.
A) The other manufacturer
B) Appropriate regulatory agency
An adverse reaction occurs in patients after the study has been completed. The
appropriate action on the part of the investigatorinclude:
a) Report the event to the sponsor.
b) Consider the event for reporting as though it was a study report.
c) Conduct causality assessment and determination of expectedness prior to expedited
reporting.
d) All of the above - d) All of the above
New safety information regarding a study drug should be updated by the sponsor by:
