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ACRP Certified Professional Sample Questions:

1. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
B) All duties transferred to a CRO should be specified in writing.
C) The IRB/IEC must approve the transfer of duties to a CRO.
D) Any trial-related duties can be documented as transferred by verbal agreement.

2. 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 family member
C) A witness
D) A legally acceptable representative

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

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

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

5. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Sample collection storage, disposal, and shipment requirements
B) Emerging animal toxicological and clinical data
C) PI roles and responsibilities
D) Project feasibility considerations

Solutions: