CITI TRAINING GCP AND REFRESHER GOOD CLINICAL
PRACTICES COURSE REVIEW 2025 2026 COURSE
QUESTION BANK VERIFIED QUESTIONS AND ANSWERS
GRADED A+ RESEARCH ETHICS COMPLIANCE STUDY
GUIDE GUARANTEED SUCCESS
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.
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
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
Who has the ultimate responsibility for the administration/dispensation of an
investigational product at the clinical site? - CORRECT ANSWER Qualified/Principal
Investigator
According to ICH E6, who should explain the correct use of the investigational product(s)
to each study subject and check, throughout the study, to see if each subject is following
the instructions properly? - CORRECT ANSWER Investigator or person designated by
the investigator
Which of the following is an important component of drug accountability? - CORRECT
ANSWER -Drug shipping and disposition records
Who has ultimate responsibility for an investigational product at the study site? -
CORRECT ANSWER -Qualified/Principal Investigator
Which of the following is part of a clinical site inspection? - CORRECT ANSWER -
Interview with study staff
Which of the following defines phase I research as it relates to non-clinical and other
phases of research: - CORRECT ANSWER -Phase I research is the first phase of
research after animal testing and helps define future phase II and III studies.
Approximately how many subjects generally participate in phase I studies? -
CORRECT ANSWER -20-80
PRACTICES COURSE REVIEW 2025 2026 COURSE
QUESTION BANK VERIFIED QUESTIONS AND ANSWERS
GRADED A+ RESEARCH ETHICS COMPLIANCE STUDY
GUIDE GUARANTEED SUCCESS
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.
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
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
Who has the ultimate responsibility for the administration/dispensation of an
investigational product at the clinical site? - CORRECT ANSWER Qualified/Principal
Investigator
According to ICH E6, who should explain the correct use of the investigational product(s)
to each study subject and check, throughout the study, to see if each subject is following
the instructions properly? - CORRECT ANSWER Investigator or person designated by
the investigator
Which of the following is an important component of drug accountability? - CORRECT
ANSWER -Drug shipping and disposition records
Who has ultimate responsibility for an investigational product at the study site? -
CORRECT ANSWER -Qualified/Principal Investigator
Which of the following is part of a clinical site inspection? - CORRECT ANSWER -
Interview with study staff
Which of the following defines phase I research as it relates to non-clinical and other
phases of research: - CORRECT ANSWER -Phase I research is the first phase of
research after animal testing and helps define future phase II and III studies.
Approximately how many subjects generally participate in phase I studies? -
CORRECT ANSWER -20-80
