CPI EXAM QUESTIONS AND ANSWERS
GRADED A+ 100% VERIFIED.
What is an Unexpected Adverse drug reaction? ANS >>> A reaction that is
not consistent with the applicable product information
Are the terms "serious" and "severe" are synonymous according to ICH.
ANS >>> No
A serious adverse event is any untoward medical occurrence which at
any dose is best described by which of the following statements?
Select all that apply
A) Results in death
B) Is life-threatening
C) Is a congenital anomaly
D) Causes cancer ANS >>> A, B and C
Which of the following options describes the term "severe" in regards
to ICH?
,A) The Intensity of a specific event
B) Regulatory reporting obligations
C) An event in which the patient was at a risk of death
D) Events usually to be considered serious ANS >>> A
Subject 3826 had to stay in the hospital for three extra days when his
legs started swelling after participation in a cardiac drug study. Swelling
of the legs was listed in the Investigator's Brochure as a possible side
effect. Which of the following options best describes this situation?
A) Severe event unrelated to the drug
B) Unexpected Adverse Drug Reaction
C) Serious Adverse Drug Reaction
D) Severe Adverse Drug Reaction ANS >>> C
A subject in your diabetes research study developed colon cancer,
which the Investigator has determined to be unrelated to the study. The
subject is currently asymptomatic.
This will be considered a serious adverse event because it is life
threatening. Is this a true or false statement? ANS >>> False
In pre-market approval studies, all noxious and unintended responses
to a medicinal product, even possibly related to any dose, should be
considered which of the following options?
,A) Unexpected Serious Adverse Event
B) Adverse Drug Reaction
C) Serious Adverse Event
D) Severe Adverse Drug Reaction ANS >>> B
A subject has a suspected serious adverse drug reaction with the
outcome of death. Per the ICH E2A guideline, which are items that
should be submitted to the Sponsor?
Select all that apply
A) A de-identified autopsy report, if available
B) The address of the next of kin so that the sponsor can write a letter
of condolence
C) Cause of death, and a comment on its possible relationship to the
suspected drug reaction
D) The name and address of the subject's General Practitioner (GP) ANS
>>> A & C
Two weeks after starting an investigational therapy, a subject is rushed
to the hospital after experiencing a heart attack. The subject is currently
being treated in the Intensive Care Unit (ICU). The ICU doctor has
noticed that the subject was enrolled in the trial and has contacted the
trial Principal Investigator. Heart attack is not described in the
Investigator's Brochure. What actions must be taken by the Principal
Investigator?
Select all that apply
, A) Report to the Sponsor per the protocol timelines for serious,
unexpected events.
B) Suspend enrolment until a cause of the event is established
C) Report to the IRB/IEC per their event reporting requirements for
serious, unexpected events
D) Revise the informed consent to reflect heart attack as a possible risk
ANS >>> A&C
What is the timeframe for "expedited" reporting of serious, fatal or life-
threatening, unexpected adverse drug reactions to regulatory
authorities?
A) As soon as possible, but no later than seven calendar days after first
knowledge of the event
B) Two days after first knowledge of the event
C) Two calendar days after the first knowledge of the event
D) One week, unless the subject has died, in which case it is 12 hours
ANS >>> A
Your third subject in a Phase III drug trial calls to report that she has
developed a rash on her chest 12 hours after taking her second dose of
the investigational study drug. She states that it itches and is slightly
uncomfortable. She tells you that she has never had a rash and this is
totally unexpected. You know from the Investigator Drug Brochure that
only 12% of the patients get a rash from this drug. Which of the
following options best describes this situation?
A) Adverse Event
GRADED A+ 100% VERIFIED.
What is an Unexpected Adverse drug reaction? ANS >>> A reaction that is
not consistent with the applicable product information
Are the terms "serious" and "severe" are synonymous according to ICH.
ANS >>> No
A serious adverse event is any untoward medical occurrence which at
any dose is best described by which of the following statements?
Select all that apply
A) Results in death
B) Is life-threatening
C) Is a congenital anomaly
D) Causes cancer ANS >>> A, B and C
Which of the following options describes the term "severe" in regards
to ICH?
,A) The Intensity of a specific event
B) Regulatory reporting obligations
C) An event in which the patient was at a risk of death
D) Events usually to be considered serious ANS >>> A
Subject 3826 had to stay in the hospital for three extra days when his
legs started swelling after participation in a cardiac drug study. Swelling
of the legs was listed in the Investigator's Brochure as a possible side
effect. Which of the following options best describes this situation?
A) Severe event unrelated to the drug
B) Unexpected Adverse Drug Reaction
C) Serious Adverse Drug Reaction
D) Severe Adverse Drug Reaction ANS >>> C
A subject in your diabetes research study developed colon cancer,
which the Investigator has determined to be unrelated to the study. The
subject is currently asymptomatic.
This will be considered a serious adverse event because it is life
threatening. Is this a true or false statement? ANS >>> False
In pre-market approval studies, all noxious and unintended responses
to a medicinal product, even possibly related to any dose, should be
considered which of the following options?
,A) Unexpected Serious Adverse Event
B) Adverse Drug Reaction
C) Serious Adverse Event
D) Severe Adverse Drug Reaction ANS >>> B
A subject has a suspected serious adverse drug reaction with the
outcome of death. Per the ICH E2A guideline, which are items that
should be submitted to the Sponsor?
Select all that apply
A) A de-identified autopsy report, if available
B) The address of the next of kin so that the sponsor can write a letter
of condolence
C) Cause of death, and a comment on its possible relationship to the
suspected drug reaction
D) The name and address of the subject's General Practitioner (GP) ANS
>>> A & C
Two weeks after starting an investigational therapy, a subject is rushed
to the hospital after experiencing a heart attack. The subject is currently
being treated in the Intensive Care Unit (ICU). The ICU doctor has
noticed that the subject was enrolled in the trial and has contacted the
trial Principal Investigator. Heart attack is not described in the
Investigator's Brochure. What actions must be taken by the Principal
Investigator?
Select all that apply
, A) Report to the Sponsor per the protocol timelines for serious,
unexpected events.
B) Suspend enrolment until a cause of the event is established
C) Report to the IRB/IEC per their event reporting requirements for
serious, unexpected events
D) Revise the informed consent to reflect heart attack as a possible risk
ANS >>> A&C
What is the timeframe for "expedited" reporting of serious, fatal or life-
threatening, unexpected adverse drug reactions to regulatory
authorities?
A) As soon as possible, but no later than seven calendar days after first
knowledge of the event
B) Two days after first knowledge of the event
C) Two calendar days after the first knowledge of the event
D) One week, unless the subject has died, in which case it is 12 hours
ANS >>> A
Your third subject in a Phase III drug trial calls to report that she has
developed a rash on her chest 12 hours after taking her second dose of
the investigational study drug. She states that it itches and is slightly
uncomfortable. She tells you that she has never had a rash and this is
totally unexpected. You know from the Investigator Drug Brochure that
only 12% of the patients get a rash from this drug. Which of the
following options best describes this situation?
A) Adverse Event
