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ACRP Certified Professional Sample Questions:

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

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

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

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

3. A Phase I drug trial has been completed and preparations are being made to proceed to a Phase II trial. Who is responsible for revising the IB with this updated information?

A) DSMB/IDMC
B) Health authority
C) Investigator
D) Sponsor

4. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Data Manager
B) Monitor
C) QA Department
D) Sponsor

5. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) Under the supervision of the PI.
B) Licensed to practice medicine.
C) Approved by the IRB/IEC.
D) An employee of the institution.

Solutions: