ACRP ACRP-CP

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ACRP Certified Professional Sample Questions:

1. During a monitoring visit, a CRA notices that a piece of equipment required for the study needs to be serviced. Who is responsible for addressing this problem?

A) Sponsor
B) CRA
C) PI
D) CRC

2. The PI did not record the relationship to IP in the medical chart when assessing an adverse event. The CRC noticed the omission and brought it to the PI's attention. How should this be addressed?

A) The PI should notify the monitor.
B) The CRC should amend the medical chart.
C) The CRC should write a note to file.
D) The PI should amend the medical chart.

3. Who must be blinded in a double-blind study in order to prevent bias?

A) Pharmacist
B) Data entry staff
C) Subject
D) IRB/IEC

4. At a close-out visit, which document should be retained only at the site?

A) Subject identification code list
B) IP accountability
C) Final trial close-out monitoring report
D) Treatment allocation

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* 3 participants were withdrawn due to noncompliance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

Solutions: