ACRP CRC EXAM QUESTION BANK
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 -
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 - Answer -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 - Answer -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. -
Answer -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. - Answer -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. -
Answer -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. - Answer -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 - Answer -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 - Answer -d) All of the above
New safety information regarding a study drug should be updated by the sponsor by:
a) Notifying the IRB
b) Notifying the investigator
c) Updating the protocol
, d) Updating the Investigator's Brochure - Answer -d) Updating the Investigator's
Brochure
An unexpected adverse drug reaction is a reaction:
a) Happens immediately after drug administration.
b) Is inconsistent with the documented product information in the investigator's brochure
or other source documents.
c) Known to occur frequently in preclinical studies.
d) Dependent on the dose of the drug - Answer -b) Is inconsistent with the documented
product information in the investigator's brochure or other source documents.
An adverse event that is severe in intensity:
a) May qualify for expedited reporting
b) Could be classified as a serious adverse event
c) May not meet the definition of a serious adverse event.
d) Need not be reported to the sponsor if it is part of the disease condition. - Answer -c)
May not meet definition of a serious adverse event.
To be characterized as severe an adverse even is one:
a) That qualifies for expedited reporting
b) Is always life threatening
c) Is always one that can be characterized as serious
d) That merely describes the intensity of the medical event. - Answer -d) That merely
describes the intensity of the medical event.
Which of the following statements is correct?
a) An adverse event is one that is always viewed as potentially serious.
b) An adverse event is an adverse drug reaction.
c) An adverse event qualifies for expedited reporting
d) None of the above - Answer -d) None 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. - 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 - Answer -d) All of the above
For expedited reporting an event must be:
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 -
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 - Answer -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 - Answer -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. -
Answer -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. - Answer -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. -
Answer -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. - Answer -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 - Answer -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 - Answer -d) All of the above
New safety information regarding a study drug should be updated by the sponsor by:
a) Notifying the IRB
b) Notifying the investigator
c) Updating the protocol
, d) Updating the Investigator's Brochure - Answer -d) Updating the Investigator's
Brochure
An unexpected adverse drug reaction is a reaction:
a) Happens immediately after drug administration.
b) Is inconsistent with the documented product information in the investigator's brochure
or other source documents.
c) Known to occur frequently in preclinical studies.
d) Dependent on the dose of the drug - Answer -b) Is inconsistent with the documented
product information in the investigator's brochure or other source documents.
An adverse event that is severe in intensity:
a) May qualify for expedited reporting
b) Could be classified as a serious adverse event
c) May not meet the definition of a serious adverse event.
d) Need not be reported to the sponsor if it is part of the disease condition. - Answer -c)
May not meet definition of a serious adverse event.
To be characterized as severe an adverse even is one:
a) That qualifies for expedited reporting
b) Is always life threatening
c) Is always one that can be characterized as serious
d) That merely describes the intensity of the medical event. - Answer -d) That merely
describes the intensity of the medical event.
Which of the following statements is correct?
a) An adverse event is one that is always viewed as potentially serious.
b) An adverse event is an adverse drug reaction.
c) An adverse event qualifies for expedited reporting
d) None of the above - Answer -d) None 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. - 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 - Answer -d) All of the above
For expedited reporting an event must be:
