GOOD CLINICAL PRACTICE COURSE (MEDICAL
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
1. A primary purpose of the ICH is to: b. Minimize the need for
a. Require FDA registration of worldwide clinical trials. redundant research
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug
development.
2. The ICH GCP guidelines: b. Set standards for the
a. Require certification of clinical research sites and design, conduct, monitor-
investigators ing and reporting of clini-
b. Set standards for the design, conduct, monitoring cal research.
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 conduct-
ed studies of drugs that will be marketed in the U.S.
3. ICH E6 describes standards that apply to: a. Investigators, sponsors,
a. Investigators, sponsors, and IRBs and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only
4. In the United States, following the ICH E6 guideline is: c. Voluntary for FDA-regu-
a. Mandatory for investigational device studies.
5. Which of the
b. Mandatory for drug studies.
following are
c. Voluntary for FDA-regulated drug studies.
the three
d. Mandatory for studies conducted outside the United
principles
States.
includ- ed in
,GOOD CLINICAL PRACTICE COURSE (MEDICAL
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
the Belmont Report? lated drug studies.
d. Respect for Persons,
Beneficence, Justice.
, GOOD CLINICAL PRACTICE COURSE (MEDICAL
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
a. IRB review, Federal regulations, Declaration of
Helsinki.
b. Informed Consent, Institutional Assurance, Re-
searcher responsibility.
c. Privacy, Confidentiality, Equitable selection of sub-
jects.
d. Respect for Persons, Beneficence, Justice.
6. Which of the following is an example of how the Princi- b. Determining that the
ple of Beneficence can be applied to a study employing study has maximized ben-
human subjects?
8. The
a. Ensuring that confidentiality is maintained.
investigator
b. Determining that the study has maximized benefits
must report
and minimized risks. adverse
c. Insuring that the selection of subjects includes peo- events to the:
ple from all segments of the population. a. FDA
d. Providing detailed information about the study and
obtaining the subject's consent to participate.
7. 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 ra-
tio.
d. Risk/benefit assessment, justification of research,
comprehension.
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
1. A primary purpose of the ICH is to: b. Minimize the need for
a. Require FDA registration of worldwide clinical trials. redundant research
b. Minimize the need for redundant research.
c. Require publication of negative trial results.
d. Develop mandatory worldwide regulations for drug
development.
2. The ICH GCP guidelines: b. Set standards for the
a. Require certification of clinical research sites and design, conduct, monitor-
investigators ing and reporting of clini-
b. Set standards for the design, conduct, monitoring cal research.
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 conduct-
ed studies of drugs that will be marketed in the U.S.
3. ICH E6 describes standards that apply to: a. Investigators, sponsors,
a. Investigators, sponsors, and IRBs and IRBs
b. IRBs only
c. Research sponsors only
d. Investigators only
4. In the United States, following the ICH E6 guideline is: c. Voluntary for FDA-regu-
a. Mandatory for investigational device studies.
5. Which of the
b. Mandatory for drug studies.
following are
c. Voluntary for FDA-regulated drug studies.
the three
d. Mandatory for studies conducted outside the United
principles
States.
includ- ed in
,GOOD CLINICAL PRACTICE COURSE (MEDICAL
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
the Belmont Report? lated drug studies.
d. Respect for Persons,
Beneficence, Justice.
, GOOD CLINICAL PRACTICE COURSE (MEDICAL
CLINICAL RESEARCH) 55 ACTUAL QUESTIONS
WITH CORRECT VERIFIED ANSWERS|| 2025
EXPERT GUARANTEED FOR PASS!!
a. IRB review, Federal regulations, Declaration of
Helsinki.
b. Informed Consent, Institutional Assurance, Re-
searcher responsibility.
c. Privacy, Confidentiality, Equitable selection of sub-
jects.
d. Respect for Persons, Beneficence, Justice.
6. Which of the following is an example of how the Princi- b. Determining that the
ple of Beneficence can be applied to a study employing study has maximized ben-
human subjects?
8. The
a. Ensuring that confidentiality is maintained.
investigator
b. Determining that the study has maximized benefits
must report
and minimized risks. adverse
c. Insuring that the selection of subjects includes peo- events to the:
ple from all segments of the population. a. FDA
d. Providing detailed information about the study and
obtaining the subject's consent to participate.
7. 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 ra-
tio.
d. Risk/benefit assessment, justification of research,
comprehension.
