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ACRP Certified Professional Sample Questions:

1. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 80%
B) 66%
C) 77%
D) 71%

2. Which document confirms the PI's agreement to permit auditing at the study site?

A) IB
B) ICF
C) Protocol
D) Delegation Log

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

4. Which entity has ultimate responsibility over the conduct of the multi-center clinical trial?

A) IRB/IEC
B) Regulatory authority
C) Sponsor-Investigator
D) CRO

5. A representative from a regulatory authority shows up unannounced at a research site. After confirming their credentials, the representative requested to view the entire records, including identifiable information, from study XYZ that was closed out. Which of the following should the site personnel do next?

A) Consult with the IRB/IEC first.
B) Allow access to the entire records.
C) Redact subject identification for privacy protection.
D) Deny the request until the sponsor approves.

Solutions: