Good Clinical Practice Course (Medical Clinical Research) Exam |
Verified Exam Questions and Answers | Latest Updated Study Material
2026
Question:
Good Clinical Practice Course (Medical Clinical Research) Exam
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.
Answer:
b. Minimize the need for redundant research
Question:
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.
Answer:
b. Set standards for the design, conduct, monitoring
and reporting of clinical research.
Question:
ICH E6 describes standards that apply to:
a. Investigators, sponsors, and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only
,Answer:
a. Investigators, sponsors, and IRBs
Question:
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.
Answer:
c.
Voluntary for FDA-regulated drug studies.
Question:
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.
Answer:
d. Respect for
Persons, Beneficence, Justice.
Question:
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.
Answer:
b. Determining that the study has maximized
, benefits and minimized risks.
Question:
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.
Answer:
b. Information, comprehension, voluntariness.
Question:
The investigator must report adverse events to the:
a. FDA
b. Subject
c. Sponsor
d. IRB only
Answer:
c. Sponsor
Question:
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
Answer:
c. Conduct or supervise
the investigation personally
Verified Exam Questions and Answers | Latest Updated Study Material
2026
Question:
Good Clinical Practice Course (Medical Clinical Research) Exam
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.
Answer:
b. Minimize the need for redundant research
Question:
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.
Answer:
b. Set standards for the design, conduct, monitoring
and reporting of clinical research.
Question:
ICH E6 describes standards that apply to:
a. Investigators, sponsors, and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only
,Answer:
a. Investigators, sponsors, and IRBs
Question:
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.
Answer:
c.
Voluntary for FDA-regulated drug studies.
Question:
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.
Answer:
d. Respect for
Persons, Beneficence, Justice.
Question:
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.
Answer:
b. Determining that the study has maximized
, benefits and minimized risks.
Question:
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.
Answer:
b. Information, comprehension, voluntariness.
Question:
The investigator must report adverse events to the:
a. FDA
b. Subject
c. Sponsor
d. IRB only
Answer:
c. Sponsor
Question:
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
Answer:
c. Conduct or supervise
the investigation personally
