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CITI Training - Good Clinical Practice Newest
2025/2026 Complete All Questions And
Correct Detailed Answers (Verified Answers)
|Already Graded A+||Brand New Version!!
Good Clinical Practice Course for Clinical Trials with
Investigational Drugs and Medical Devices - . . ANSWER
✔✔
Which of the following are the three principles included in
the Belmont Report? - . . ANSWER ✔ ✔Respect for
Persons, Beneficence, Justice.
Which of the following is an example of how the Principle
of Beneficence can be applied to a study employing human
subjects? - . . ANSWER ✔ ✔Determining that the study
has maximized benefits and minimized risks.
Which of the following best describes the principle of
Respect for Persons as described in the Belmont Report? -
. . ANSWER ✔ ✔Information, comprehension,
voluntariness.
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Investigator Obligations in FDA-Regulated Research - . .
ANSWER ✔ ✔
When must the investigator update the IRB about the
progress of a trial? - . . ANSWER ✔ ✔During the conduct
of the study and at termination
Form FDA 1572, Statement of Investigator, is legally
binding between the investigator and the: - . . ANSWER ✔
✔FDA
The investigator must report adverse events to the: - . .
ANSWER ✔ ✔Sponser
In completing Form FDA 1572, Statement of Investigator,
the investigator agrees to - . . ANSWER ✔ ✔Conduct or
supervise the investigation personally
Which of the following is an investigator's commitment to
the sponsor? - . . ANSWER ✔ ✔Submit a new Form FDA
1572 to the sponsor as needed
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Informed Consent in Clinical Trials of Drugs, Biologics,
and Devices - . . ANSWER ✔ ✔
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.
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.
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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.
Overview of New Drug Development - . . ANSWER ✔ ✔
Development of most new drugs, from discovery to
marketing approval, usually takes: - . . ANSWER ✔ ✔9
years or more
Adults with more than a twelve (12)-month history of
migraines were assigned randomly in a double-blinded
study to receive treatment with experimental drug X (10 or
20 mg/day) or placebo. The primary efficacy measure was
the reduction in severity of the migraine attacks.
Enrollment was twelve-hundred (1200) subjects. Which of
the following best describes the clinical phase of this
study? - . . ANSWER ✔ ✔Phase III
CITI Training - Good Clinical Practice Newest
2025/2026 Complete All Questions And
Correct Detailed Answers (Verified Answers)
|Already Graded A+||Brand New Version!!
Good Clinical Practice Course for Clinical Trials with
Investigational Drugs and Medical Devices - . . ANSWER
✔✔
Which of the following are the three principles included in
the Belmont Report? - . . ANSWER ✔ ✔Respect for
Persons, Beneficence, Justice.
Which of the following is an example of how the Principle
of Beneficence can be applied to a study employing human
subjects? - . . ANSWER ✔ ✔Determining that the study
has maximized benefits and minimized risks.
Which of the following best describes the principle of
Respect for Persons as described in the Belmont Report? -
. . ANSWER ✔ ✔Information, comprehension,
voluntariness.
,2|Page
Investigator Obligations in FDA-Regulated Research - . .
ANSWER ✔ ✔
When must the investigator update the IRB about the
progress of a trial? - . . ANSWER ✔ ✔During the conduct
of the study and at termination
Form FDA 1572, Statement of Investigator, is legally
binding between the investigator and the: - . . ANSWER ✔
✔FDA
The investigator must report adverse events to the: - . .
ANSWER ✔ ✔Sponser
In completing Form FDA 1572, Statement of Investigator,
the investigator agrees to - . . ANSWER ✔ ✔Conduct or
supervise the investigation personally
Which of the following is an investigator's commitment to
the sponsor? - . . ANSWER ✔ ✔Submit a new Form FDA
1572 to the sponsor as needed
,3|Page
Informed Consent in Clinical Trials of Drugs, Biologics,
and Devices - . . ANSWER ✔ ✔
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.
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.
, 4|Page
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.
Overview of New Drug Development - . . ANSWER ✔ ✔
Development of most new drugs, from discovery to
marketing approval, usually takes: - . . ANSWER ✔ ✔9
years or more
Adults with more than a twelve (12)-month history of
migraines were assigned randomly in a double-blinded
study to receive treatment with experimental drug X (10 or
20 mg/day) or placebo. The primary efficacy measure was
the reduction in severity of the migraine attacks.
Enrollment was twelve-hundred (1200) subjects. Which of
the following best describes the clinical phase of this
study? - . . ANSWER ✔ ✔Phase III
