ACRP Certified Professional Sample Questions:

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

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

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

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

3. Who takes responsibility for initiating a clinical trial?

A) CRO
B) IRB/IEC
C) Sponsor
D) Investigator

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

5. During a mid-study sponsor audit of a clinical trial, the auditor notices that all of the protocol-required subject drug dosing diaries were incomplete. The effect of this will be the inability to:

A) Evaluate study data.
B) Verify compliance with IP regimen.
C) Conduct safety analysis.
D) Validate protocol endpoints.

Solutions: