CITI TRAINING QUIZ ACTUAL EXAM 200 QUESTIONS
AND CORRECT DETAILED ANSWERS||AGRADE
What are the three principles discussed in the Belmont Report? - ANSWER: Justice,
Beneficence, and Respect for Persons
Which of the following is an example of how the Principle of Beneficence can be
applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining the subject's
consent to participate.
B. Insuring that the selection of subjects includes people from all segments of the
population.
C. Determining that the study has maximized benefits and minimized risks.
D. Ensuring that confidentiality is maintained. - ANSWER: C. Determining that the
study has a maximization of benefits and a minimization of risks.
Which of the following best describes the principle of informed consent as described
in the Belmont Report?
A. Voluntariness, risk/benefit assessment, selection of subjects.
B. Comprehension, conflicts of interest, risk/benefit ratio.
C. Risk/benefit assessment, justification of research, comprehension.
D. Information, comprehension, voluntariness. - ANSWER: D. Information,
Comprehension, voluntariness.
Development of most new drugs from discovery to marketing approval usually takes:
- ANSWER: 9 years or more
Adults with more than a 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 1200 subjects. Which of the following best
describes the clinical phase of this study? - ANSWER: Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which
part of drug development? - ANSWER: Preclinical
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational
drug most likely refers to which clinical phase of a study in humans? - ANSWER:
Phase I
For a phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? - ANSWER: Preclinical data
A primary purpose of the ICH is to - ANSWER: Minimize the need for redundant
research.
, The ICH GCP Guidelines - ANSWER: Set standards for the design, conduct, monitoring
and reporting of clinical research.
The ICH E6 GCP describes standards that apply to - ANSWER: Investigators, sponsors,
and IRBs.
In the United States, following the ICH E6 guideline is - ANSWER: Voluntary for FDA-
regulated drug studies.
The new ICH E6 integrated addendum (R2) 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? - ANSWER: Identification of
study risks to determine which may safely be omitted from continual monitoring.
What is the legal status of ICH in U.S.? - ANSWER: It is a FDA guidance
In terms of explaining the probability of assignment to trial arms in consent forms,
which is true? - ANSWER: ICH notes that it should be included, but does not specify
how the information should be presented.
Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations? - ANSWER: The FDA regulations allow subjects or the
legally acceptable representatives (LARs) to receive either a signed or unsigned copy
The new ICH E6 integrated addendum (R2) 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? - 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
Identify which party is responsible for reporting directly to the FDA the investigator's
financial interests with the sponsor: - ANSWER: The sponsor
The investigator must report adverse events to the - ANSWER: Sponsor.
In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: -
ANSWER: Conduct or supervise the investigation personally.
Form FDA 1572, Statement of Investigator, is legally binding between the
Investigator and the: - ANSWER: FDA.
When must the investigator update the IRB about the progress of a trial? - ANSWER:
During the conduct of the study and at termination
Which of the following is an important component of drug accountability? -
ANSWER: Drug shipping and disposition records
AND CORRECT DETAILED ANSWERS||AGRADE
What are the three principles discussed in the Belmont Report? - ANSWER: Justice,
Beneficence, and Respect for Persons
Which of the following is an example of how the Principle of Beneficence can be
applied to a study employing human subjects?
A. Providing detailed information about the study and obtaining the subject's
consent to participate.
B. Insuring that the selection of subjects includes people from all segments of the
population.
C. Determining that the study has maximized benefits and minimized risks.
D. Ensuring that confidentiality is maintained. - ANSWER: C. Determining that the
study has a maximization of benefits and a minimization of risks.
Which of the following best describes the principle of informed consent as described
in the Belmont Report?
A. Voluntariness, risk/benefit assessment, selection of subjects.
B. Comprehension, conflicts of interest, risk/benefit ratio.
C. Risk/benefit assessment, justification of research, comprehension.
D. Information, comprehension, voluntariness. - ANSWER: D. Information,
Comprehension, voluntariness.
Development of most new drugs from discovery to marketing approval usually takes:
- ANSWER: 9 years or more
Adults with more than a 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 1200 subjects. Which of the following best
describes the clinical phase of this study? - ANSWER: Phase III
Long-term toxicology of an experimental drug in animals most likely refers to which
part of drug development? - ANSWER: Preclinical
Pharmacokinetics and pharmacodynamics of a new formulation of an investigational
drug most likely refers to which clinical phase of a study in humans? - ANSWER:
Phase I
For a phase I new drug study in humans, what is the primary source of the data
included in the initial Investigator's Brochure? - ANSWER: Preclinical data
A primary purpose of the ICH is to - ANSWER: Minimize the need for redundant
research.
, The ICH GCP Guidelines - ANSWER: Set standards for the design, conduct, monitoring
and reporting of clinical research.
The ICH E6 GCP describes standards that apply to - ANSWER: Investigators, sponsors,
and IRBs.
In the United States, following the ICH E6 guideline is - ANSWER: Voluntary for FDA-
regulated drug studies.
The new ICH E6 integrated addendum (R2) 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? - ANSWER: Identification of
study risks to determine which may safely be omitted from continual monitoring.
What is the legal status of ICH in U.S.? - ANSWER: It is a FDA guidance
In terms of explaining the probability of assignment to trial arms in consent forms,
which is true? - ANSWER: ICH notes that it should be included, but does not specify
how the information should be presented.
Regarding subject receipt of a signed and dated copy of the consent forms, which is
true about FDA regulations? - ANSWER: The FDA regulations allow subjects or the
legally acceptable representatives (LARs) to receive either a signed or unsigned copy
The new ICH E6 integrated addendum (R2) 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? - 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
Identify which party is responsible for reporting directly to the FDA the investigator's
financial interests with the sponsor: - ANSWER: The sponsor
The investigator must report adverse events to the - ANSWER: Sponsor.
In completing Form FDA 1572, Statement of Investigator, the Investigator agrees to: -
ANSWER: Conduct or supervise the investigation personally.
Form FDA 1572, Statement of Investigator, is legally binding between the
Investigator and the: - ANSWER: FDA.
When must the investigator update the IRB about the progress of a trial? - ANSWER:
During the conduct of the study and at termination
Which of the following is an important component of drug accountability? -
ANSWER: Drug shipping and disposition records
