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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A) Data Manager
B) Sponsor
C) CRO
D) CRA

2. 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) Risk-based audits of CRO activities as delegated
C) Pre-qualification assessment of CRO
D) Central monitoring of data fields by sponsor

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

4. 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) Update the IB to add the risk of infection and submit to the sponsor for approval.
C) Add the risk of infection to the ICF and submit to the IRB/IEC for review.
D) Notify the sponsor of the change in study plan and submit the deviation to the IRB/IEC for review.

5. When assessing the monitoring needs for a study, sponsors should:

A) Permit PIs to select a monitor for their site as long as they are independent of the PI.
B) Use central monitoring instead of conducting physical monitoring visits at sites.
C) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
D) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.

Solutions: