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ACRP Certified Professional Sample Questions:

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

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

2. Which of the following documents is maintained by a PI to ensure compliance with sponsor requirements?

A) Regulatory submission of protocol and accompanying documents to relevant regulatory authority.
B) Training records of site personnel on study protocol, and their study-related duties and functions.
C) A monitoring report that identifies deviation from the approved protocol.
D) A monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial.

3. The composition of an IDMC/DSMB should include which one of the following?

A) A sponsor representative who is knowledgeable about the study's unblinded information
B) A member from the IRB/IEC
C) A clinical scientist who is knowledgeable in the appropriate discipline
D) A lead PI for the study

4. SAEs must be reported immediately by the site to the:

A) IRB/IEC.
B) DSMB/IDMC.
C) Regulatory agency.
D) Sponsor.

5. 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) Sponsor
B) CRO
C) CRC
D) PI

Solutions: