CPI Exam Questions 2026
Exam All Answers and
Illustrations Given
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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
Exam All Answers and
Illustrations Given
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
COPYRIGHT©PROFFKERRYMARTIN 2025/2026. YEAR PUBLISHED 2026. COMPANY REGISTRATION NUMBER: 619652435. TERMS OF USE.
PRIVACY STATEMENT. ALL RIGHTS RESERVED
, 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
