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ACRP Certified Professional Sample Questions:

1. The sponsor calls the site and informs the research team that they have decided to temporarily suspend the study. What step should the research team take FIRST?

A) Schedule participant for early termination visit.
B) Inform the IRB/IEC of the study closure.
C) Inform participant and assure proper care is provided.
D) Inform the monitor of the termination of the study.

2. A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?

A) Original
B) Complete
C) Contemporaneous
D) Attributable

3. Centralized monitoring can:

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

4. A study to determine the effective dose and regimen of a new IP for the treatment of hypothyroidism is considered to be:

A) Phase II
B) Phase III
C) Phase I
D) Phase IV

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

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

Solutions: