MEGA SOCRA CCRP EXAM 2025
CONTENT
ANSWER ALL QUESTIONS IN THIS SECTION
QUESTION 1
Which of the following is the proper way to make a correction to a CRF?
Add the initials of the person making the change, the date of the change, and, if
necessary, a brief explanation of the change.
QUESTION 2
What details need to be documented in the subject source documentation
when an Adverse Event (AE) occurs? Select all that apply
A. The severity of the event
B. When the event occurred
C. Setting in which the event occurred
QUESTION 3
What is an Unexpected Adverse drug reaction?
A reaction that is not consistent with the applicable product information
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, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 4
The terms "serious" and "severe" are synonymous according to ICH.
FALSE
QUESTION 5
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
QUESTION 6
. Which of the following options describes the term "severe" in regards to
ICH?
The Intensity of a specific event
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PAGE 2
, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 7
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?
Serious Adverse Drug Reaction
QUESTION 8
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?
FALSE
QUESTION 9
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?
Adverse Drug Reaction
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PAGE 3
, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 10
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?
1. A de-identified autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the suspected drug
reaction
QUESTION 11
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?
1. Report to the Sponsor per the protocol timelines for serious, unexpected events.
2. Report to the IRB/IEC per their event reporting requirements for serious,
unexpected events.
END OF
PAGE 4
CONTENT
ANSWER ALL QUESTIONS IN THIS SECTION
QUESTION 1
Which of the following is the proper way to make a correction to a CRF?
Add the initials of the person making the change, the date of the change, and, if
necessary, a brief explanation of the change.
QUESTION 2
What details need to be documented in the subject source documentation
when an Adverse Event (AE) occurs? Select all that apply
A. The severity of the event
B. When the event occurred
C. Setting in which the event occurred
QUESTION 3
What is an Unexpected Adverse drug reaction?
A reaction that is not consistent with the applicable product information
END OF
PAGE 1
, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 4
The terms "serious" and "severe" are synonymous according to ICH.
FALSE
QUESTION 5
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
QUESTION 6
. Which of the following options describes the term "severe" in regards to
ICH?
The Intensity of a specific event
END OF
PAGE 2
, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 7
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?
Serious Adverse Drug Reaction
QUESTION 8
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?
FALSE
QUESTION 9
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?
Adverse Drug Reaction
END OF
PAGE 3
, MEGA SOCRA CCRP EXAM 2025
CONTENT
QUESTION 10
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?
1. A de-identified autopsy report, if available
2. Cause of death, and a comment on its possible relationship to the suspected drug
reaction
QUESTION 11
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?
1. Report to the Sponsor per the protocol timelines for serious, unexpected events.
2. Report to the IRB/IEC per their event reporting requirements for serious,
unexpected events.
END OF
PAGE 4
