Description
ACRP Practice Exam Questions AND
ANSWERS GRADED A LATEST
2023/2024
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. -
CORRECT ANSWERS 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 - CORRECT ANSWERS 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 - CORRECT ANSWERS To observe
the consent process
A medical student is approached by a faculty member for