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ACRP Certified Professional Sample Questions:

1. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) ICF
B) Package insert
C) IB
D) Protocol

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

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

3. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Establish a DSMB/IDMC
B) Draft a CAPA plan
C) Develop a monitoring plan
D) Conduct routine investigators' meetings

4. What would a sponsor use to implement and maintain quality in a study?

A) Statistical analysis plan
B) Protocol signature pages
C) Clinical trial agreement
D) Standard operating procedures

5. The sponsor should supply a PI with the IP after:

A) Approval of protocol by the sponsor.
B) Approval of protocol by the PI.
C) Submission of documents to IRB/IEC and regulatory authority for review.
D) Approval/favorable opinion from IRB/IEC and regulatory authority.

Solutions: