ACRP Certified Professional : ACRP-CP

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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. The sponsor must report a serious unexpected AE to the regulatory authorities within a maximum of:

A) 8 calendar days
B) 30 calendar days
C) 15 calendar days
D) 7 calendar days

2. 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 IV
C) Phase III
D) Phase I

3. Which of the following statements is TRUE about an EDC system?

A) A separate workstation should be made available for the monitor.
B) IRB/IEC approval is required before the use of the computerized system.
C) There should be an audit trail to track data entries, deletions, and changes.
D) The eCRF should be an exact page-by-page replica of the paper CRF.

4. A clinical trial is conducted to test the effect of an investigational drug on cholesterol levels. Statistical analysis will be performed to:

A) Reject the alternative hypothesis that the drug has no effect on cholesterol levels.
B) Reject the null hypothesis that the drug has no effect on cholesterol levels.
C) Fail to reject the alternative hypothesis that the drug has an effect on cholesterol levels.
D) Fail to reject the null hypothesis that the drug has an effect on cholesterol levels.

5. The PI may assign responsibility for IP accountability to the pharmacist provided they are:

A) An employee of the institution.
B) Licensed to practice medicine.
C) Approved by the IRB/IEC.
D) Under the supervision of the PI.

Solutions: