CITI Training - Good Clinical Practice Exam | All
Questions and Correct Answers | Already
Graded A+ | Verified Answers | Latest Version
2025 | Just Released
In terms of explaining the probability of assignment to trial arms in consent forms,
which is true? ---------CORRECT ANSWER-----------------ICH notes that it should be
included, but does not specify how the information should be presented.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are complying with
ICH E6 guideline, they must: ---------CORRECT ANSWER-----------------Clearly
disclose to subjects in the informed consent form that the monitor, auditor,
IRB/IEC, and the regulatory authorities may have access to the subject's medical
records
Regarding subject receipt of a signed and dated copy of the consent forms, which
is true about FDA regulations? ---------CORRECT ANSWER-----------------The FDA
regulations allow subjects or the legally acceptable representatives (LARs) to
receive either a signed or unsigned copy.
The new ICH E6(R2) integrated addendum requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The system
should use a risk-based approach including which of the following? ---------
, CORRECT ANSWER-----------------Identification of study risks to determine which
may safely be omitted from continual monitoring.
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? ---------
CORRECT ANSWER-----------------IND report
Who is responsible for making the initial risk determination for a device being
used in a study? ---------CORRECT ANSWER-----------------The sponsor-investigator.
Which of the following is an acceptable criterion for determining that a study of
an approved drug does not require an IND? ---------CORRECT ANSWER-----------------
The study is not intended to be reported to FDA to support a new indication or
support a labeling change.
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.
Questions and Correct Answers | Already
Graded A+ | Verified Answers | Latest Version
2025 | Just Released
In terms of explaining the probability of assignment to trial arms in consent forms,
which is true? ---------CORRECT ANSWER-----------------ICH notes that it should be
included, but does not specify how the information should be presented.
ICH E6 has broader requirements than FDA or HHS concerning confidentiality of
medical records and access by third parties. If investigators are complying with
ICH E6 guideline, they must: ---------CORRECT ANSWER-----------------Clearly
disclose to subjects in the informed consent form that the monitor, auditor,
IRB/IEC, and the regulatory authorities may have access to the subject's medical
records
Regarding subject receipt of a signed and dated copy of the consent forms, which
is true about FDA regulations? ---------CORRECT ANSWER-----------------The FDA
regulations allow subjects or the legally acceptable representatives (LARs) to
receive either a signed or unsigned copy.
The new ICH E6(R2) integrated addendum requires sponsors to implement
systems to manage quality throughout all stages of the trial process. The system
should use a risk-based approach including which of the following? ---------
, CORRECT ANSWER-----------------Identification of study risks to determine which
may safely be omitted from continual monitoring.
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? ---------
CORRECT ANSWER-----------------IND report
Who is responsible for making the initial risk determination for a device being
used in a study? ---------CORRECT ANSWER-----------------The sponsor-investigator.
Which of the following is an acceptable criterion for determining that a study of
an approved drug does not require an IND? ---------CORRECT ANSWER-----------------
The study is not intended to be reported to FDA to support a new indication or
support a labeling change.
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.
