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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) All duties transferred to a CRO should be specified in writing.
B) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
C) The IRB/IEC must approve the transfer of duties to a CRO.
D) Any trial-related duties can be documented as transferred by verbal agreement.

2. Which statement does NOT represent a study monitor's responsibilities?

A) Report serious adverse events to the IRB/IEC.
B) Check the accuracy and completeness of case report forms with source documents.
C) Provide communication between the sponsor and the PI.
D) Verify that the PI has adequate qualifications and resources to conduct the study.

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

4. The objective of a randomized clinical trial is to look at whether an IP is effective in preventing recurrence of a disease. What would be a possible primary endpoint of the trial?

A) Time to occurrence of symptoms of the disease
B) Impact of an approved vaccine against the disease
C) Occurrence of known side effects of the IP
D) Use of concomitant medications to treat the symptoms

5. The composition of an IDMC/DSMB should include which one of the following?

A) A clinical scientist who is knowledgeable in the appropriate discipline
B) A lead PI for the study
C) A member from the IRB/IEC
D) A sponsor representative who is knowledgeable about the study's unblinded information

Solutions: