1|Page
CITI GOOD CLINICAL PRACTICE COURSE (US
FDA FOCUS) 2025 ; Brand New Certified
Exam With Verified Questions And Correct
Answers.
Which of the following are the three principles included in the Belmont
Report? - Correct-Answer-Respect for Persons, Beneficence, Justice.
Investigational product dispensing or administration information for
the sponsor is recorded on the: - Correct-Answer-Case report form
The packaging of investigational drugs should ideally: - Correct-Answer-
Be designed to help with subject compliance
Where is information on storage requirements for the investigational
product usually found? - Correct-Answer-In the study protocol
, 2|Page
An investigator conducting a study of a medical device under an IDE is
required to complete and sign which of the following? - Correct-
Answer-An investigator's agreement
A 510(k) Premarket Notification is submitted: - Correct-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: - Correct-Answer-Sponsor
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:
- Correct-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.
CITI GOOD CLINICAL PRACTICE COURSE (US
FDA FOCUS) 2025 ; Brand New Certified
Exam With Verified Questions And Correct
Answers.
Which of the following are the three principles included in the Belmont
Report? - Correct-Answer-Respect for Persons, Beneficence, Justice.
Investigational product dispensing or administration information for
the sponsor is recorded on the: - Correct-Answer-Case report form
The packaging of investigational drugs should ideally: - Correct-Answer-
Be designed to help with subject compliance
Where is information on storage requirements for the investigational
product usually found? - Correct-Answer-In the study protocol
, 2|Page
An investigator conducting a study of a medical device under an IDE is
required to complete and sign which of the following? - Correct-
Answer-An investigator's agreement
A 510(k) Premarket Notification is submitted: - Correct-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: - Correct-Answer-Sponsor
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:
- Correct-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.
