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ACRP Certified Professional Sample Questions:

1. A deferred consent can take place in which of the following situations?

A) Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
B) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.
C) In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
D) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.

2. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Schedule a site initiation visit
B) Verify subject eligibility
C) Ship/receive IP
D) Obtain IRB/IEC approval

3. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Applicable site SOPs
B) Sponsor
C) Applicable regulatory authorities
D) PI

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

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

5. Which of the following activities is the MOST efficient way of overseeing a CRO's management during a clinical trial?

A) Risk-based audits of CRO activities as delegated
B) Pre-qualification assessment of CRO
C) Co-monitoring of CRO site visits
D) Central monitoring of data fields by sponsor

Solutions: