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ACRP Certified Professional Sample Questions:

1. Who is responsible for the ongoing safety evaluation of the IP?

A) Sponsor
B) PI
C) Regulatory agency
D) IRB/IEC

2. At a close-out visit, which document should be retained only at the site?

A) IP accountability
B) Final trial close-out monitoring report
C) Treatment allocation
D) Subject identification code list

3. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Notify the PI.
B) Report a protocol deviation to the IRB/IEC.
C) Notify the sponsor.
D) Call the participant to return for an unscheduled visit.

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

5. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, IB, and information about payments and compensation available to subjects
B) Protocol, site coordinator CVs, and clinical trial agreement
C) Protocol, informed consent, and clinical trial agreement
D) IB, site coordinator CVs, and information about payments and compensation available to subjects

Solutions: