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ACRP Certified Professional Sample Questions:

1. A double-blind randomized Phase III trial seeks to recruit 500 subjects in 2 years. At the end of the first year,
150 subjects have been enrolled. Monitoring reports from the first year note 50% of subjects screened were screen failures due to exclusionary lab values. What action should the sponsor take?

A) Evaluate the screen failures to determine if the protocol needs revision.
B) Reduce the target sample size based on feedback from the sites.
C) Allocate additional monitoring resources to the trial.
D) Re-train investigators on recruitment obligations.

2. 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* 3 participants were withdrawn due to noncompliance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) 4 participants
C) 5 participants
D) 6 participants

3. Which of the following is a conflict of interest for a PI conducting a study?

A) A PI that presents at an investigator meeting
B) A PI that votes on the IRB/IEC approval of the protocol
C) A PI who is a key opinion leader, writes the protocol
D) A PI who receives payment for the study

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

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

5. When designing a clinical trial, why is it important to define the study population?

A) To determine where to conduct the study
B) To support the study objectives
C) To determine the study objectives
D) To support subject recruitment to the study

Solutions: