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ACRP Certified Professional Sample Questions:

1. Who is responsible for defining, establishing, and allocating all trial-related duties and functions prior to initiating a trial?

A) CRO
B) Investigator
C) IRB/IEC
D) Sponsor

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

3. Who determines what criteria and procedures should be followed if a subject discontinues/withdraws their consent?

A) CRO
B) Subject
C) PI
D) Sponsor

4. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 3 participants
B) 5 participants
C) 6 participants
D) 4 participants

5. A root cause analysis should be:

A) Specific to a clinical trial.
B) Focused on issues of non-compliance.
C) Written by the investigator.
D) Validated before use in a CAPA.

Solutions: