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CITI Training — Good Clinical Practice
(GCP) Course 2025: Certification,
Modules, and Exam Answers
Complete your CITI Training Good Clinical Practice (GCP) certification 2025 with the latest
modules, quiz answers, and training updates. Learn essential principles of clinical research
ethics, informed consent, investigator responsibilities, and regulatory compliance to meet
FDA, ICH, and NIH requirements for GCP certification.
CITI Training Good Clinical Practice 2025
• CITI GCP certification course
• Good Clinical Practice training online
A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - ANSWER-Discuss the pros
and cons of both the investigational drug and the commercially available drug and then allow the subject
to decide whether to withdraw from the research to take the new drug
An investigator is confronted with a life-threatening situation that necessitates using a test article in a
human subject who is unable to provide informed consent and there is no time to obtain consent from
the individual's legal representative. Under the FDA regulations, which of the following describes the
best course of action for the investigator: - ANSWER-The investigator and another physician who is not
part of the study team agree that the situation necessitates the use of the test article and the IRB will be
notified later.
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Which of the following statements in a consent form is an example of exculpatory language? - ANSWER-I
waive any possibility of compensation for injuries that I may receive as a result of participation in this
research.
Under which circumstance does the FDA allow verbal consent prior to participation in a research study? -
ANSWER-The study is minimal risk.
When evaluating the causality of an adverse event, which of the following should be a consideration? -
ANSWER-The timing of the event in relation to administration of the investigational agent
Accurate reporting of adverse events is most important for: - ANSWER-Ensuring subject safety.
A subject is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist
and mild concussion. The subject was treated and released from the emergency department. What
should the investigator do when learning of the crash? - ANSWER-Report adverse events of both a
broken wrist and a mild concussion.
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of
breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a
history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a
phase I study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event? - ANSWER-Principal Investigator
The sponsor must submit an IND safety report to the FDA if an adverse event is (1) serious; (2)
unexpected; AND: - ANSWER-(3) there is a reasonable possibility that the drug caused the event.
Which of the following is an acceptable criterion for determining that a study of an approved drug does
not require an IND? - ANSWER-The study is not intended to be reported to FDA to support a new
indication or support a labeling change.
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for
annual reporting of which one of the following to FDA? - ANSWER-IND report
CITI Training — Good Clinical Practice
(GCP) Course 2025: Certification,
Modules, and Exam Answers
Complete your CITI Training Good Clinical Practice (GCP) certification 2025 with the latest
modules, quiz answers, and training updates. Learn essential principles of clinical research
ethics, informed consent, investigator responsibilities, and regulatory compliance to meet
FDA, ICH, and NIH requirements for GCP certification.
CITI Training Good Clinical Practice 2025
• CITI GCP certification course
• Good Clinical Practice training online
A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy.
While the study is ongoing, a new drug becomes commercially available that may have equal or greater
benefit to the subject. The investigator should do which of the following? - ANSWER-Discuss the pros
and cons of both the investigational drug and the commercially available drug and then allow the subject
to decide whether to withdraw from the research to take the new drug
An investigator is confronted with a life-threatening situation that necessitates using a test article in a
human subject who is unable to provide informed consent and there is no time to obtain consent from
the individual's legal representative. Under the FDA regulations, which of the following describes the
best course of action for the investigator: - ANSWER-The investigator and another physician who is not
part of the study team agree that the situation necessitates the use of the test article and the IRB will be
notified later.
, 2|Page
Which of the following statements in a consent form is an example of exculpatory language? - ANSWER-I
waive any possibility of compensation for injuries that I may receive as a result of participation in this
research.
Under which circumstance does the FDA allow verbal consent prior to participation in a research study? -
ANSWER-The study is minimal risk.
When evaluating the causality of an adverse event, which of the following should be a consideration? -
ANSWER-The timing of the event in relation to administration of the investigational agent
Accurate reporting of adverse events is most important for: - ANSWER-Ensuring subject safety.
A subject is a passenger in a car involved in a motor vehicle crash. The subject sustained a broken wrist
and mild concussion. The subject was treated and released from the emergency department. What
should the investigator do when learning of the crash? - ANSWER-Report adverse events of both a
broken wrist and a mild concussion.
A subject presents to the emergency department (ED) with complaints of chest pain and shortness of
breath. Blood studies are positive for a heart attack and the subject is hospitalized. The subject has a
history of coronary artery disease. The subject reports to the ED nurse that he is currently enrolled in a
phase I study of a new lipid lowering agent. Which individual should determine causality of the serious
adverse event? - ANSWER-Principal Investigator
The sponsor must submit an IND safety report to the FDA if an adverse event is (1) serious; (2)
unexpected; AND: - ANSWER-(3) there is a reasonable possibility that the drug caused the event.
Which of the following is an acceptable criterion for determining that a study of an approved drug does
not require an IND? - ANSWER-The study is not intended to be reported to FDA to support a new
indication or support a labeling change.
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for
annual reporting of which one of the following to FDA? - ANSWER-IND report
