ACRP Certified Professional : ACRP-CP exam

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) PD affected participant safety.
B) Sponsor approved the PD.
C) Participant verbally agreed to the PD.
D) PD affected participant recruitment.

2. Upon receipt of temperature-controlled IP, the study staff noticed the IP incurred a temperature excursion during transport. What should the staff do NEXT?

A) Dispose of IP and request replacement from sponsor.
B) Quarantine IP without registering in IWRS and request replacement from sponsor.
C) Register IP in IWRS and continue with subject allocation.
D) Register IP in IWRS, quarantine and notify sponsor of the excursion.

3. 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.

4. 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) Factorial
D) Group sequential

5. Which of the following would the sponsor need to do FIRST to set up an effective clinical trial quality management system (QMS)?

A) Train the research coordinator on the required study assessments schedule.
B) Identify critical processes and data during protocol development.
C) Perform a periodic review to see if the quality methods are effective and relevant.
D) Determine the quality tolerance limits for data transcription errors.

Solutions: