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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A. Co-monitoring of CRO site visits
B. Pre-qualification assessment of CRO
C. Central monitoring of data fields by sponsor
D. Risk-based audits of CRO activities as delegated

Question 2

An audit was recently completed and identified non-compliance that could potentially affect the reliability of study results. Who should perform a root cause analysis and implement appropriatecorrective and preventive actions?

A. PI
B. IRB/IEC
C. DSMB/IDMC
D. Sponsor

Question 3

The IB contains which of the following sections?

A. Participant eligibility criteria
B. Known pharmacokinetic effects
C. Participant dosing schedule
D. IP preparation instructions

Question 4

Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A. PI
B. Applicable site SOPs
C. Sponsor
D. Applicable regulatory authorities

Question 5

A root cause analysis should be:

A. Written by the investigator.
B. Specific to a clinical trial.
C. Validated before use in a CAPA.
D. Focused on issues of non-compliance.

Solutions: