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ACRP Certified Professional Sample Questions:
1. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?
A) The number of unique eCRF templates was not specified.
B) The list of comparable technology solutions was not included.
C) The number of users with access was not defined.
D) The frequency of data backup was not defined.
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) Before accepting this site, report the risk to the trial sponsor and await their decision.
C) Before accepting this site, ensure the refrigerator is calibrated and functioning properly.
D) Accept this site and implement and maintain QA and QC systems with written SOPs.
3. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?
A) Parallel Group
B) Crossover
C) Group sequential
D) Factorial
4. A study subject inadvertently disposed of IP medication bottles. The site should report this to the:
A) Medical monitor.
B) IRB/IEC.
C) Sponsor.
D) Regulatory authority.
5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:
A) Sponsor
B) PI
C) Applicable site SOPs
D) Applicable regulatory authorities
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: C | Question # 5 Answer: D |



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