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ACRP Certified Professional Sample Questions:

1. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

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

2. Who is responsible for outlining written procedures in a study to assure that changes or corrections in CRFs are documented, are necessary, and are endorsed by the investigator?

A) CRA
B) Data Manager
C) CRO
D) Sponsor

3. A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A) Phase III
B) Phase IV
C) Phase II
D) Phase I

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

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

5. A study sponsor approaches a facility about participating in their research study. The study sponsor requires use of social media as its sole method of recruitment. The site knows their institutional IRB/IEC does not approve of social media recruiting. How should the site respond?

A) Rely on the sponsor to notify the IRB/IEC.
B) Use a central IRB/IEC.
C) Recruit for the study without use of social media.
D) Decline the study.

Solutions: