ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025

ACRP Practice Exam Questions and Correct Answers 100% Verified 2024/2025 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 Answer: 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 Answer: 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 Answer: 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