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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. What would a sponsor use to implement and maintain quality in a study?

A) Protocol signature pages
B) Clinical trial agreement
C) Statistical analysis plan
D) Standard operating procedures

2. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A) The site receives approval from the medical monitor to begin enrolling.
B) A signed clinical trial agreement between the site and sponsor is in place.
C) The CRA has performed source document review and verification at the site.
D) The DSMB meets and the first DSMB meeting report has been issued.

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

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

4. Which of the following elements of the Informed Consent are NOT required?

A) A description of potential benefits
B) Subject legal rights can be waived
C) A description of any reasonably foreseeable risks or discomforts
D) Statement that study involves research

5. Which of the following statements is TRUE about an EDC system?

A) A separate workstation should be made available for the monitor.
B) IRB/IEC approval is required before the use of the computerized system.
C) There should be an audit trail to track data entries, deletions, and changes.
D) The eCRF should be an exact page-by-page replica of the paper CRF.

Solutions: