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

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) A monitoring report that identifies deviation from the approved protocol.
B) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
C) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.
D) Training records of site personnel on study protocol, and their study-related duties and functions.

3. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Clinical Monitoring Plan
C) Standard Operating Procedure
D) Data & Safety Monitoring Plan

4. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A family member
B) A witness
C) A legally acceptable representative
D) A member of the research team

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

Solutions: