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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

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

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

2. A hospital site is being considered for a trial that requires the IP refrigerator to be continuously monitored using the sponsor-provided Wi-Fi-enabled thermometer. The hospital's Wi-Fi connectivity is inconsistent.
During site selection, how should the CRA proceed?

A) Accept this site and plan to undertake routine safety evaluations of the IP.
B) Accept this site and implement and maintain QA and QC systems with written SOPs.
C) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D) Before accepting this site, report the risk to the trial sponsor and await their decision.

3. A protocol requires participants to take 1 tablet of IP per day. At each visit, participants are supplied with enough IP for 35 days. They are asked to return any unused IP at the next visit. One participant returns at the
1-month visit at 30 days with 10 tablets of unused IP and at the 2-month visit at 60 days with 12 tablets of unused IP. What is the participant's overall compliance?

A) 71%
B) 66%
C) 77%
D) 80%

4. 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.

5. Who is responsible for submitting a protocol amendment to the IRB/IEC?

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

Solutions: