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ACRP Certified Professional Sample Questions:

1. 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) Co-monitoring of CRO site visits
D) Central monitoring of data fields by sponsor

2. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the sponsor.
B) Notify the regulatory authority.
C) Withdraw the subject.
D) Notify the subject.

3. Upon receiving their first dose of study drug in the clinic, the subject exhibits an immediately life-threatening reaction. The protocol prohibits any concomitant medications. What should be the investigator's IMMEDIATE response?

A) Consult the IB.
B) Report the AE to the sponsor.
C) Call the medical monitor.
D) Administer rescue medication.

4. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Obtain IRB/IEC approval
B) Ship/receive IP
C) Schedule a site initiation visit
D) Verify subject eligibility

5. Source data/documentation should be:

A) Attributable, legible, correct, original, accurate, and clear.
B) Attributable, legible, correct, original, accurate, and complete.
C) Attributable, legible, contemporaneous, original, accurate, and clear.
D) Attributable, legible, contemporaneous, original, accurate, and complete.

Solutions: