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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Standard Operating Procedure
C) Data & Safety Monitoring Plan
D) Clinical Monitoring Plan

2. A clinical trial where participants will be randomized to receive a sequence of two medications has which design configuration?

A) Factorial
B) Parallel Group
C) Group sequential
D) Crossover

3. Which of the following should be considered when implementing a risk-based monitoring plan?

A) 100% source document review is mandatory.
B) On-site monitoring frequency may change depending on the quality of the data.
C) Monitoring schedule must be pre-defined in the monitoring plan.
D) Centralized monitoring must be incorporated in any trials.

4. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

A) CRC
B) Sponsor
C) PI
D) CRA

5. Prior to initiation of a clinical trial, review by an IRB/IEC is required for which of the following documents?

A) Protocol, IB, and information about payments and compensation available to subjects
B) IB, site coordinator CVs, and information about payments and compensation available to subjects
C) Protocol, informed consent, and clinical trial agreement
D) Protocol, site coordinator CVs, and clinical trial agreement

Solutions: