Page |1
CITI TRAINING - GOOD CLINICAL PRACTICE NEWEST
2025/2026 NEWEST ACTUAL EXAM WITH COMPLETE
QUESTIONS AND VERIFIED ANSWERS |ALREADY GRADED
A+|
Where is information on storage requirements for the
investigational product usually found? - ANSWER-In the study
protocol
An investigator conducting a study of a medical device under an
IDE is required to complete and sign which of the following? -
ANSWER-An investigator's agreement
A 510(k) Premarket Notification is submitted: - ANSWER-When
the new device to be marketed is substantially similar (equivalent)
to one already on the market
Evaluation of Unanticipated Adverse Device Effects (UADEs)
must be reported to the FDA by the: - ANSWER-Sponsor
, Page |2
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.
Which of the following statements in a consent form is an
example of exculpatory language? - ANSWER-I waive any
CITI TRAINING - GOOD CLINICAL PRACTICE NEWEST
2025/2026 NEWEST ACTUAL EXAM WITH COMPLETE
QUESTIONS AND VERIFIED ANSWERS |ALREADY GRADED
A+|
Where is information on storage requirements for the
investigational product usually found? - ANSWER-In the study
protocol
An investigator conducting a study of a medical device under an
IDE is required to complete and sign which of the following? -
ANSWER-An investigator's agreement
A 510(k) Premarket Notification is submitted: - ANSWER-When
the new device to be marketed is substantially similar (equivalent)
to one already on the market
Evaluation of Unanticipated Adverse Device Effects (UADEs)
must be reported to the FDA by the: - ANSWER-Sponsor
, Page |2
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.
Which of the following statements in a consent form is an
example of exculpatory language? - ANSWER-I waive any
