Good Clinical Practice Course
(Medical Clinical Research) Exam
Questions and Answers 100% PASS
A primary purpose of the ICH is to:
a. Require FDA registration of worldwide clinical trials.
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug development. - CORRECT
ANSWER-b. Minimize the need for redundant research
The ICH GCP guidelines:
a. Require certification of clinical research sites and investigators
b. Set standards for the design, conduct, monitoring and reporting of clinical
research.
c. Guarantee that a submission in any ICH region will be approved for marketing.
,d. Replace FDA regulations for internationally conducted studies of drugs that will
be marketed in the U.S. - CORRECT ANSWER-b. Set standards for the design,
conduct, monitoring and reporting of clinical research.
ICH E6 describes standards that apply to:
a. Investigators, sponsors, and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only - CORRECT ANSWER-a. Investigators, sponsors, and IRBs
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. - CORRECT
ANSWER-c. Voluntary for FDA-regulated drug studies.
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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
, c. Privacy, Confidentiality, Equitable selection of subjects.
d. Respect for Persons, Beneficence, Justice. - CORRECT ANSWER-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. - CORRECT ANSWER-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. - CORRECT
ANSWER-b. Information, comprehension, voluntariness.
(Medical Clinical Research) Exam
Questions and Answers 100% PASS
A primary purpose of the ICH is to:
a. Require FDA registration of worldwide clinical trials.
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug development. - CORRECT
ANSWER-b. Minimize the need for redundant research
The ICH GCP guidelines:
a. Require certification of clinical research sites and investigators
b. Set standards for the design, conduct, monitoring and reporting of clinical
research.
c. Guarantee that a submission in any ICH region will be approved for marketing.
,d. Replace FDA regulations for internationally conducted studies of drugs that will
be marketed in the U.S. - CORRECT ANSWER-b. Set standards for the design,
conduct, monitoring and reporting of clinical research.
ICH E6 describes standards that apply to:
a. Investigators, sponsors, and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only - CORRECT ANSWER-a. Investigators, sponsors, and IRBs
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. - CORRECT
ANSWER-c. Voluntary for FDA-regulated drug studies.
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.
COPYRIGHT ©️ 2025 ALL RIGHTS RESERVED
, c. Privacy, Confidentiality, Equitable selection of subjects.
d. Respect for Persons, Beneficence, Justice. - CORRECT ANSWER-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. - CORRECT ANSWER-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. - CORRECT
ANSWER-b. Information, comprehension, voluntariness.
