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ACRP Certified Professional Sample Questions:

1. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 15 calendar days
B) 30 calendar days
C) 8 calendar days
D) 7 calendar days

2. After the site qualification visit report has been finalized, it must be:

A) Included in the PI's regulatory file.
B) Sent to the IRB/IEC for review and approval.
C) Stored in the sponsor's budgets and contracts file.
D) Kept in the CRO/sponsor's trial master file.

3. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Complete
B) Original
C) Contemporaneous
D) Attributable

4. After the completion or termination of a clinical trial, who should store the enrollment log?

A) PI
B) CRO
C) Sponsor
D) Regulatory authority

5. Per protocol, participants are scheduled to receive IP, which is calculated based on the participant's current weight. Unknown to the pharmacist, a participant recently lost 15 pounds and was overdosed as a result. What is the FIRST action the CRC must take to ensure the participant's safety?

A) Notify the PI.
B) Report a protocol deviation to the IRB/IEC.
C) Notify the sponsor.
D) Call the participant to return for an unscheduled visit.

Solutions: