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ACRP Certified Professional Sample Questions:

1. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Principal Investigator
B) Subject's primary care physician
C) Medical monitor
D) Study pharmacovigilance physician

2. 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) Investigator at each site
C) Study sponsor
D) Original reporting investigator

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

4. 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) Standard Operating Procedure
C) Data & Safety Monitoring Plan
D) Clinical Monitoring Plan

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

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

Solutions: