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ACRP Certified Professional Sample Questions:

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

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

2. 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) Data Manager
B) QA Department
C) Monitor
D) Sponsor

3. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) PI
B) CRC
C) Regulatory Agency
D) Sponsor

4. What would a sponsor use to implement and maintain quality in a study?

A) Standard operating procedures
B) Statistical analysis plan
C) Clinical trial agreement
D) Protocol signature pages

5. All of the following are steps to assure an effective risk management approach while conducting a clinical study EXCEPT:

A) Assessing risk based on study impact.
B) Controlling risk by setting thresholds of risk acceptability.
C) Documenting all possible risk scenarios.
D) Identifying potential study risks.

Solutions: