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ACRP Certified Professional Sample Questions:

1. After the site qualification visit report has been finalized, it must be:

A) Sent to the IRB/IEC for review and approval.
B) Included in the PI's regulatory file.
C) Kept in the CRO/sponsor's trial master file.
D) Stored in the sponsor's budgets and contracts file.

2. Which of the following reports should be retained in participant charts?

A) IRB/IEC progress reports
B) Safety reports
C) DSMB/IDMC reports
D) Lab reports

3. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Privacy controls
B) Blinding
C) Randomization
D) Placebo-controlled

4. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

A) PI
B) Sponsor
C) CRO
D) CRC

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

Solutions: