ACRP ACRP-CP actual dump : ACRP Certified Professional Exam

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A) Submit the diary to the sponsor for approval.
B) No approval is necessary: give the diary to each subject.
C) Submit the diary to the regulatory authority for approval.
D) Submit the diary to the IRB/IEC for approval.

2. An investigator participating in a multicenter clinical trial has had 2 of the 4 subjects admitted to the emergency room for life-threatening infections. The investigator made the decision to stop treatment with IP and test for infections in the remaining subjects. What are the NEXT steps the investigator should take?

A) Discontinue current subjects from the study and monitor subjects for any anticipated safety events.
B) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.
C) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
D) Update the IB to add the risk of infection and submit to the sponsor for approval.

3. Which one of the following is a primary objective of a Phase III study of a new IP?

A) To establish the safety profile
B) To demonstrate or confirm therapeutic benefit
C) To show superiority over another treatment
D) To establish dose information

4. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) CRO
B) Sponsor-Investigator
C) Regulatory authority
D) IRB/IEC

5. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A) Verify compliance with IP regimen.
B) Validate protocol endpoints.
C) Conduct safety analysis.
D) Evaluate study data.

Solutions: