1
GOOD CLINICAL PRACTICE COURSE (MEDICAL CLINICAL
RESEARCH) LATEST REAL EXAM QUESTIONS & VERIFIED
ANSWERS (2026) – PASS GUARANTEED
In the United States, following the ICH E6 guideline is:
a. Mandatory for investigational device studies.
b. Mandatory for drug studies.
c. Voluntary for FDA-regulated drug studies.
d. Mandatory for studies conducted outside the United States.
c. Voluntary for FDA-regulated drug studies.
In completing Form FDA 1572, Statement of Investigator, the investigator agrees
to
a. Maintain records indefinitely
b. Report to the FDA any adverse events that occur
c. Conduct or supervise the investigation personally
d. Maintain a contract with the sponsor
c. Conduct or supervise the investigation personally
When must the investigator update the IRB about the progress of a trial?
a. During the conduct of the study only
b. During the conduct of the study and at termination
c. Never
d. At study termination only
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b. During the conduct of the study and at termination
Which of the following are the three principles included in the Belmont Report?
a. IRB review, Federal regulations, Declaration of Helsinki.
b. Informed Consent, Institutional Assurance, Researcher responsibility.
c. Privacy, Confidentiality, Equitable selection of subjects.
d. Respect for Persons, Beneficence, Justice.
d. 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?
a. Ensuring that confidentiality is maintained.
b. Determining that the study has maximized benefits and minimized risks.
c. Insuring that the selection of subjects includes people from all segments of the
population.
d. Providing detailed information about the study and obtaining the subject's
consent to participate.
b. 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?
a. Voluntariness, risk/benefit assessment, selection of subjects.
b. Information, comprehension, voluntariness.
c. Comprehension, conflicts of interest, risk/benefit ratio.
d. Risk/benefit assessment, justification of research, comprehension.
b. Information, comprehension, voluntariness.
The investigator must report adverse events to the:
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a. FDA
b. Subject
c. Sponsor
d. IRB only
c. Sponsor
Form FDA 1572, Statement of Investigator, is legally binding between the
investigator and the:
a. FDA
b. Subjects
c. IRB
d. Sponsor
a. FDA
Identify which party is responsible for reporting directly to the FDA the
investigator's financial interests with the sponsor:
a. The sponsor
b. The IRB
c. The investigator's institution
d. The investigator
a. The sponsor
Under which circumstance does the FDA allow verbal consent prior to
participation in a research study?
a. The study is minimal risk.
b. The subject is illiterate.
c. The study is greater than minimal risk.
GOOD CLINICAL PRACTICE COURSE (MEDICAL CLINICAL
RESEARCH) LATEST REAL EXAM QUESTIONS & VERIFIED
ANSWERS (2026) – PASS GUARANTEED
In the United States, following the ICH E6 guideline is:
a. Mandatory for investigational device studies.
b. Mandatory for drug studies.
c. Voluntary for FDA-regulated drug studies.
d. Mandatory for studies conducted outside the United States.
c. Voluntary for FDA-regulated drug studies.
In completing Form FDA 1572, Statement of Investigator, the investigator agrees
to
a. Maintain records indefinitely
b. Report to the FDA any adverse events that occur
c. Conduct or supervise the investigation personally
d. Maintain a contract with the sponsor
c. Conduct or supervise the investigation personally
When must the investigator update the IRB about the progress of a trial?
a. During the conduct of the study only
b. During the conduct of the study and at termination
c. Never
d. At study termination only
, 2
b. During the conduct of the study and at termination
Which of the following are the three principles included in the Belmont Report?
a. IRB review, Federal regulations, Declaration of Helsinki.
b. Informed Consent, Institutional Assurance, Researcher responsibility.
c. Privacy, Confidentiality, Equitable selection of subjects.
d. Respect for Persons, Beneficence, Justice.
d. 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?
a. Ensuring that confidentiality is maintained.
b. Determining that the study has maximized benefits and minimized risks.
c. Insuring that the selection of subjects includes people from all segments of the
population.
d. Providing detailed information about the study and obtaining the subject's
consent to participate.
b. 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?
a. Voluntariness, risk/benefit assessment, selection of subjects.
b. Information, comprehension, voluntariness.
c. Comprehension, conflicts of interest, risk/benefit ratio.
d. Risk/benefit assessment, justification of research, comprehension.
b. Information, comprehension, voluntariness.
The investigator must report adverse events to the:
, 3
a. FDA
b. Subject
c. Sponsor
d. IRB only
c. Sponsor
Form FDA 1572, Statement of Investigator, is legally binding between the
investigator and the:
a. FDA
b. Subjects
c. IRB
d. Sponsor
a. FDA
Identify which party is responsible for reporting directly to the FDA the
investigator's financial interests with the sponsor:
a. The sponsor
b. The IRB
c. The investigator's institution
d. The investigator
a. The sponsor
Under which circumstance does the FDA allow verbal consent prior to
participation in a research study?
a. The study is minimal risk.
b. The subject is illiterate.
c. The study is greater than minimal risk.
