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ACRP Certified Professional Sample Questions:

1. Which of the following reports should be retained in participant charts?

A) Safety reports
B) Lab reports
C) IRB/IEC progress reports
D) DSMB/IDMC reports

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

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

3. Centralized monitoring can:

A) Indicate the need to send monitors to perform onsite visits.
B) Confirm why sites are deviating from the protocol.
C) Enable appropriate stratification of subject enrollment.
D) Identify IP accountability and storage issues.

4. In preparation for an upcoming site audit, whose responsibility is it to ensure study-related functions were conducted by qualified personnel?

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

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* 3 participants were withdrawn due to noncompliance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

Solutions: