CITI Training - Good Clinical
Practice Exam Questions and
Answers Graded A+
Good Clinical Practice Course for Clinical Trials with Investigational Drugs and
Medical Devices - CORRECT ANSWER-
Which of the following are the three principles included in the Belmont Report? -
CORRECT 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? - CORRECT 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? - CORRECT ANSWER-Information,
comprehension, voluntariness.
Investigator Obligations in FDA-Regulated Research - CORRECT ANSWER-
When must the investigator update the IRB about the progress of a trial? -
CORRECT ANSWER-During the conduct of the study and at termination
, Form FDA 1572, Statement of Investigator, is legally binding between the
investigator and the: - CORRECT ANSWER-FDA
The investigator must report adverse events to the: - CORRECT ANSWER-
Sponser
In completing Form FDA 1572, Statement of Investigator, the investigator agrees
to - CORRECT ANSWER-Conduct or supervise the investigation personally
Which of the following is an investigator's commitment to the sponsor? -
CORRECT ANSWER-Submit a new Form FDA 1572 to the sponsor as needed
Informed Consent in Clinical Trials of Drugs, Biologics, and Devices - CORRECT
ANSWER-
Which of the following statements in a consent form is an example of exculpatory
language? - CORRECT 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? - CORRECT 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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
Practice Exam Questions and
Answers Graded A+
Good Clinical Practice Course for Clinical Trials with Investigational Drugs and
Medical Devices - CORRECT ANSWER-
Which of the following are the three principles included in the Belmont Report? -
CORRECT 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? - CORRECT 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? - CORRECT ANSWER-Information,
comprehension, voluntariness.
Investigator Obligations in FDA-Regulated Research - CORRECT ANSWER-
When must the investigator update the IRB about the progress of a trial? -
CORRECT ANSWER-During the conduct of the study and at termination
, Form FDA 1572, Statement of Investigator, is legally binding between the
investigator and the: - CORRECT ANSWER-FDA
The investigator must report adverse events to the: - CORRECT ANSWER-
Sponser
In completing Form FDA 1572, Statement of Investigator, the investigator agrees
to - CORRECT ANSWER-Conduct or supervise the investigation personally
Which of the following is an investigator's commitment to the sponsor? -
CORRECT ANSWER-Submit a new Form FDA 1572 to the sponsor as needed
Informed Consent in Clinical Trials of Drugs, Biologics, and Devices - CORRECT
ANSWER-
Which of the following statements in a consent form is an example of exculpatory
language? - CORRECT 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? - CORRECT 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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
