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CITI TRAINING GCP AND REFRESHER
|PERFECTLY REVISED QUESTIONS AND
ANSWERS 2026
A healthy volunteer is considering participating in a research study testing a new
vaccine for Ebola. He has left his glasses at home and he is unable to read the
informed consent form. According to ICH E6, who must be present during the
discussion of informed consent? - correct-answer - An impartial witness
According to ICH E6, for a clinical trial in which there are no expected benefits to
subjects (that is, a non-therapeutic trial), which of the following must apply in
regards to informed consent for subjects unable to give their consent personally
and must use a legally acceptable representative (LAR)? - correct-answer - The
objectives of the trial cannot be met by means of a trial in subjects who can give
informed consent personally.
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Subject 311 has had elevated white blood cell (WBC) counts for the past two (2)
study visits, with no clinical signs or symptoms. "Increased WBC count" is not
listed in the Investigator's Brochure (IB) as an adverse event. The investigator
should: - correct-answer - Report the elevated WBC to the sponsor as an
unexpected adverse effect.
A study subject reports that he has been having headaches for years but they
seem to have become more frequent since starting the study. The investigator
believes this is not related to the study medication. How would a clinical research
coordinator document this event? - correct-answer - This event would be an
adverse event because the complaint is more frequent headaches since starting
the study.
In ICH E6, what is the difference between an adverse event (AE) and adverse drug
reaction (ADR)? - correct-answer - An adverse drug reaction is a response to the
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investigational product and an adverse event may or may not be a response to
the investigational product.
When evaluating the causality of an adverse event, which of the following should
be a consideration? - correct-answer - The timing of the event in relation to
administration of the investigational product
A study subject breaks his leg in a skating accident. Is this incident a Serious
Adverse Event (SAE)? - correct-answer - Yes - if the subject stayed in hospital
overnight or had serious complications.
The packaging of investigational drugs should ideally - correct-answer - Be
designed to help with subject compliance
CITI TRAINING GCP AND REFRESHER
|PERFECTLY REVISED QUESTIONS AND
ANSWERS 2026
A healthy volunteer is considering participating in a research study testing a new
vaccine for Ebola. He has left his glasses at home and he is unable to read the
informed consent form. According to ICH E6, who must be present during the
discussion of informed consent? - correct-answer - An impartial witness
According to ICH E6, for a clinical trial in which there are no expected benefits to
subjects (that is, a non-therapeutic trial), which of the following must apply in
regards to informed consent for subjects unable to give their consent personally
and must use a legally acceptable representative (LAR)? - correct-answer - The
objectives of the trial cannot be met by means of a trial in subjects who can give
informed consent personally.
,2|Page
Subject 311 has had elevated white blood cell (WBC) counts for the past two (2)
study visits, with no clinical signs or symptoms. "Increased WBC count" is not
listed in the Investigator's Brochure (IB) as an adverse event. The investigator
should: - correct-answer - Report the elevated WBC to the sponsor as an
unexpected adverse effect.
A study subject reports that he has been having headaches for years but they
seem to have become more frequent since starting the study. The investigator
believes this is not related to the study medication. How would a clinical research
coordinator document this event? - correct-answer - This event would be an
adverse event because the complaint is more frequent headaches since starting
the study.
In ICH E6, what is the difference between an adverse event (AE) and adverse drug
reaction (ADR)? - correct-answer - An adverse drug reaction is a response to the
, 3|Page
investigational product and an adverse event may or may not be a response to
the investigational product.
When evaluating the causality of an adverse event, which of the following should
be a consideration? - correct-answer - The timing of the event in relation to
administration of the investigational product
A study subject breaks his leg in a skating accident. Is this incident a Serious
Adverse Event (SAE)? - correct-answer - Yes - if the subject stayed in hospital
overnight or had serious complications.
The packaging of investigational drugs should ideally - correct-answer - Be
designed to help with subject compliance
