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ACRP Certified Professional Sample Questions:

1. A serious unexpected ADR is one:

A) Where the severity of the reaction is not consistent with IB.
B) That does not need to be reported to the IRB/IEC.
C) Severity and nature of the reaction is consistent with protocol.
D) That results in the death of the subject.

2. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Regulatory Agency
B) Sponsor
C) CRC
D) PI

3. 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.

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

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

5. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:

A) Review the content for ethically or morally sensitive issues.
B) Assure the ads do not impinge on confidentiality agreements.
C) Safeguard the rights, safety, and well-being of all potential subjects.
D) Confirm subjects receive the appropriate reimbursement.

Solutions: