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ACRP Certified Professional Sample Questions:

1. The inclusion and exclusion criteria are in place so all subjects are:

A) Patients with the disease under study and will not have any adverse events.
B) Medically appropriate and protected from ethical vulnerability.
C) Healthy and willing to complete the clinical trial.
D) Ethically vulnerable and patients with the disease under study.

2. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, informed consent, and clinical trial agreement
B) Protocol, site coordinator CVs, and clinical trial agreement
C) IB, site coordinator CVs, and information about payments and compensation available to subjects
D) Protocol, IB, and information about payments and compensation available to subjects

3. Which strategy is used to safeguard subject privacy?

A) Store source documentation in the CRC's office.
B) Conduct subject-related conversations in controlled environments.
C) Utilize subject initials on correspondence.
D) Email updated enrollment logs to the CRA.

4. Which of the following should be considered when implementing a risk-based monitoring plan?

A) 100% source document review is mandatory.
B) On-site monitoring frequency may change depending on the quality of the data.
C) Monitoring schedule must be pre-defined in the monitoring plan.
D) Centralized monitoring must be incorporated in any trials.

5. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Principal Investigator
B) Subject's primary care physician
C) Medical monitor
D) Study pharmacovigilance physician

Solutions: