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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

2. Who ensures information regarding payments to subjects is documented in a written consent form?

A) Coordinator
B) Sponsor
C) IRB/IEC
D) PI

3. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) Sponsor
B) CRO
C) IRB/IEC
D) Investigator

4. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Study pharmacovigilance physician
B) Medical monitor
C) Principal Investigator
D) Subject's primary care physician

5. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Develop a monitoring plan
B) Conduct routine investigators' meetings
C) Establish a DSMB/IDMC
D) Draft a CAPA plan

Solutions: