ACRP PRACTICE EXAM QUESTIONS
WITH 100% CORRECT ANSWERS {
GUARANTEED A+}
A research study, in which there is no intended clinical benefit to the
subject, is being submitted to the IRB/IEC. What benefit information
should be included in the ICF?
a.
The benefits section should be left out of the ICF, as it is not applicable.
b.
Wording indicating that there is no expected benefit should be included.
c.
A section on the benefits of clinical research in general should be added.
,d.
A description of the subject visit stipends should be included as a
benefit. - ✔✔Wording indicating that there is no expected benefit
should be included
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks or
inconveniences?
reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations.Ref 1 Page: 4.8.10 - ✔✔ICF
When would an impartial witness be needed during the consent process
for an illiterate subject?
,Reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations. Ref 1 Page: 4.8.9 - ✔✔To observe the consent process
A medical student is approached by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of
the following increases risk to the subject?
a.Consenting in the presence of PI
b.Offering a stipend for participating in the study
c.
Allowing flexibility in scheduling research visits
d.
Consenting in the presence of figure of authority
reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations. Ref 1 Page: 1.61 - ✔✔Consenting in the presence of
figure of authority
, An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR, and protocol therapy was initiated. The subject
showed significant improvement in his clinical condition, and regained
consciousness. The Investigator should inform the subject about the
study and:
a.obtain assent from the subject for the study.
b.
tell the subject he is benefiting from the study therapy.
c.
obtain consent from the subject for the study.
d.
tell the subject that an LAR provided consent for his participation.
WITH 100% CORRECT ANSWERS {
GUARANTEED A+}
A research study, in which there is no intended clinical benefit to the
subject, is being submitted to the IRB/IEC. What benefit information
should be included in the ICF?
a.
The benefits section should be left out of the ICF, as it is not applicable.
b.
Wording indicating that there is no expected benefit should be included.
c.
A section on the benefits of clinical research in general should be added.
,d.
A description of the subject visit stipends should be included as a
benefit. - ✔✔Wording indicating that there is no expected benefit
should be included
A blood sample collection is required to screen for bloodborne
pathogens before subject could be enrolled in a study. Where will
subjects find information of the procedures and any foreseeable risks or
inconveniences?
reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations.Ref 1 Page: 4.8.10 - ✔✔ICF
When would an impartial witness be needed during the consent process
for an illiterate subject?
,Reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations. Ref 1 Page: 4.8.9 - ✔✔To observe the consent process
A medical student is approached by a faculty member for possible
participation in a cricothyroidotomy simulation research study. Which of
the following increases risk to the subject?
a.Consenting in the presence of PI
b.Offering a stipend for participating in the study
c.
Allowing flexibility in scheduling research visits
d.
Consenting in the presence of figure of authority
reference ICH E6 (R2), section-topic: Ethical and Participant Safety
Considerations. Ref 1 Page: 1.61 - ✔✔Consenting in the presence of
figure of authority
, An unconscious adult subject was enrolled in a study after obtaining
consent from an LAR, and protocol therapy was initiated. The subject
showed significant improvement in his clinical condition, and regained
consciousness. The Investigator should inform the subject about the
study and:
a.obtain assent from the subject for the study.
b.
tell the subject he is benefiting from the study therapy.
c.
obtain consent from the subject for the study.
d.
tell the subject that an LAR provided consent for his participation.
