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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

Question 1

An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites' IRB/IECs?

A. Investigator at each site
B. Original reporting investigator
C. Study sponsor
D. Regulatory authority

Question 2

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

Question 3

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

Question 4

When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A. Sponsor approved the PD.
B. Participant verbally agreed to the PD.
C. PD affected participant recruitment.
D. PD affected participant safety.

Question 5

After the completion or termination of a clinical trial, who should store the enrollment log?

A. PI
B. Sponsor
C. Regulatory authority
D. CRO

Solutions: