ACRP Practice Exam Questions | 100% Correct
Answers | Verified | Latest 2024 Version
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.
reference Declaration of Helsinki; section-topic: Ethical and Participant Safety Considerations. -
✔✔obtain consent from the subject for the study.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
a.The subject's primary physician
b.
The subject's legally acceptable representative
c.
The impartial witness
d.
The subject's significant other - ✔✔The subject's legally acceptable representative
, An investigator is notified by the sponsor that a study will terminate. The PI would like to continue to
follow the subjects for another year. What should the PI do?
a.
Continue following the subjects in the study
b.
Request permission from the IRB/IEC to continue the study
c.
Consent subjects to a new IRB/IEC approved protocol
d.
Request IP from the sponsor to continue the study
reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations, Ref 1 Page: 5.21. -
✔✔Consent subjects to a new IRB/IEC approved protocol
Which of the following is an optional section of the IB?
a.Safety and Efficacy
b.
Marketing Experience
c.
Non-clinical Studies
d.
Signature Page
reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations, Ref 1 Page: 7.5
Appendix 2. - ✔✔Signature Page
A PI is having challenges retaining subjects in the follow-up portion of a clinical trial. He decides to offer
gift cards to them for each visit they attend. What should the PI do to initiate this option?
a.Tell the CRC to purchase the gift cards and notify patients
Answers | Verified | Latest 2024 Version
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.
reference Declaration of Helsinki; section-topic: Ethical and Participant Safety Considerations. -
✔✔obtain consent from the subject for the study.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
a.The subject's primary physician
b.
The subject's legally acceptable representative
c.
The impartial witness
d.
The subject's significant other - ✔✔The subject's legally acceptable representative
, An investigator is notified by the sponsor that a study will terminate. The PI would like to continue to
follow the subjects for another year. What should the PI do?
a.
Continue following the subjects in the study
b.
Request permission from the IRB/IEC to continue the study
c.
Consent subjects to a new IRB/IEC approved protocol
d.
Request IP from the sponsor to continue the study
reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations, Ref 1 Page: 5.21. -
✔✔Consent subjects to a new IRB/IEC approved protocol
Which of the following is an optional section of the IB?
a.Safety and Efficacy
b.
Marketing Experience
c.
Non-clinical Studies
d.
Signature Page
reference ICH E6 (R2), section-topic: Ethical and Participant Safety Considerations, Ref 1 Page: 7.5
Appendix 2. - ✔✔Signature Page
A PI is having challenges retaining subjects in the follow-up portion of a clinical trial. He decides to offer
gift cards to them for each visit they attend. What should the PI do to initiate this option?
a.Tell the CRC to purchase the gift cards and notify patients
