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ACRP Certified Professional Sample Questions:

1. While reviewing reports of data completion, the sponsor notices low retention rates at many participating sites. What is an appropriate FIRST action for the sponsor to take?

A) Require participants to provide documented reason for withdrawal.
B) Submit revised ICFs to the IRB/IEC with increased compensation for participants.
C) Meet with the site staff to understand their workflows and to review retention strategies.
D) Interview participants who have dropped out.

2. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

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

3. All of the following are examples of what monitors review EXCEPT:

A) Documentation in the participant's medical record of study drug administration.
B) The signed ICF retained in the participant's study file.
C) Potential patient medical records for eligibility prior to the informed consent process.
D) Regulatory binder which includes copies of current certifications for all laboratories.

4. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The number of unique eCRF templates was not specified.
B) The frequency of data backup was not defined.
C) The number of users with access was not defined.
D) The list of comparable technology solutions was not included.

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

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

Solutions: