CITI Good Clinical Practice Course (US FDA focus) EXAM
2025/2026 ACTUAL COMPLETE REAL EXAM QUESTIONS
AND CORRECT ANSWERS | 100% VERIFIED ANSWERS
/ALREADY PASSED!! GRADED A+ /2025 BRAND NEW
VERSION!!
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 for 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 not part of the study team
agree that the situation necessitates the use of the test article
and the IRB will be notified later.
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.
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.
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
The overall goal of monitoring, audits, and inspection
activities is to: -
ANSWER-Ensure the protection of human research subjects
and data integrity.
According to ICH E6, an inspection is defined as: - ANSWER-
An official review
2025/2026 ACTUAL COMPLETE REAL EXAM QUESTIONS
AND CORRECT ANSWERS | 100% VERIFIED ANSWERS
/ALREADY PASSED!! GRADED A+ /2025 BRAND NEW
VERSION!!
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 for 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 not part of the study team
agree that the situation necessitates the use of the test article
and the IRB will be notified later.
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.
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.
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
The overall goal of monitoring, audits, and inspection
activities is to: -
ANSWER-Ensure the protection of human research subjects
and data integrity.
According to ICH E6, an inspection is defined as: - ANSWER-
An official review
