CPI exam questions
What is an Unexpected Adverse drug reaction? - Answer-A reaction that is not consistent with the
applicable product information
Are the terms "serious" and "severe" are synonymous according to ICH. - Answer-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 - Answer-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 - Answer-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 - Answer-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? - Answer-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 - Answer-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) - Answer-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 enrollment 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 - Answer-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 - Answer-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
B) Adverse Drug Reaction
C) Unexpected Adverse Drug Reaction
D) Serious Adverse Drug Reaction - Answer-B
What is the purpose of the IRB/IEC?
A) Safeguard the rights, safety, and well-being of all trial subjects
B) To monitor clinical trials
, C) To design trial protocols
D) To choose the appropriate Principal Investigator at the Site level - Answer-A
Who is responsible for designing the clinical trial protocol?
A) Investigator
B) Sponsor
C) Institution
D) IRB/IEC - Answer-B
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial
is best described as which of the following options?
A) IRB/IEC Approval
B) Legally Authorized Agreement
C) Intent to Treat
D) Informed Consent Process - Answer-D
Who is ultimately responsible for Source Data Verification or SDV? - Answer-Monitor
The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications
and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It
is recommended that the IRB/IEC should include which of the following options?
Select all that apply
A) At least five members
B) At least one member whose primary interest is non-scientific
C) At least one member who is independent from the Institution/trial site
D) At least one member who is employed by the study sponsor - Answer-A, B, C
What is an Unexpected Adverse drug reaction? - Answer-A reaction that is not consistent with the
applicable product information
Are the terms "serious" and "severe" are synonymous according to ICH. - Answer-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 - Answer-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 - Answer-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 - Answer-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? - Answer-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 - Answer-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) - Answer-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 enrollment 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 - Answer-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 - Answer-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
B) Adverse Drug Reaction
C) Unexpected Adverse Drug Reaction
D) Serious Adverse Drug Reaction - Answer-B
What is the purpose of the IRB/IEC?
A) Safeguard the rights, safety, and well-being of all trial subjects
B) To monitor clinical trials
, C) To design trial protocols
D) To choose the appropriate Principal Investigator at the Site level - Answer-A
Who is responsible for designing the clinical trial protocol?
A) Investigator
B) Sponsor
C) Institution
D) IRB/IEC - Answer-B
The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial
is best described as which of the following options?
A) IRB/IEC Approval
B) Legally Authorized Agreement
C) Intent to Treat
D) Informed Consent Process - Answer-D
Who is ultimately responsible for Source Data Verification or SDV? - Answer-Monitor
The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications
and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It
is recommended that the IRB/IEC should include which of the following options?
Select all that apply
A) At least five members
B) At least one member whose primary interest is non-scientific
C) At least one member who is independent from the Institution/trial site
D) At least one member who is employed by the study sponsor - Answer-A, B, C
