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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. IP is dispensed to all subjects who:

A) Are eligible to receive it in the trial.
B) Consented for the trial.
C) Need IP for their medical condition.
D) Screened for the trial.

2. At a close-out visit, which document should be retained only at the site?

A) Treatment allocation
B) IP accountability
C) Final trial close-out monitoring report
D) Subject identification code list

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

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

4. A serious unexpected ADR is one:

A) Where the severity of the reaction is not consistent with IB.
B) That does not need to be reported to the IRB/IEC.
C) Severity and nature of the reaction is consistent with protocol.
D) That results in the death of the subject.

5. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Monitor
B) Sponsor
C) Data Manager
D) QA Department

Solutions: