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ACRP Certified Professional Sample Questions:

1. Who is responsible for the ongoing safety evaluation of the IP?

A) IRB/IEC
B) Regulatory agency
C) PI
D) Sponsor

2. A root cause analysis should be:

A) Specific to a clinical trial.
B) Written by the investigator.
C) Focused on issues of non-compliance.
D) Validated before use in a CAPA.

3. 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) CRA
C) PI
D) Sponsor

4. A study has been closed for two years after the last approval of a marketing application of an IP. No additional applications are pending and there are no further developments planned for the IP. Which of the following statements is the BEST course of action regarding the destruction of the essential documents?

A) The site should retain the essential documents longer to meet the regulatory requirements.
B) The site should contact the sponsor and receive written notification prior to destruction that the essential documents are no longer needed.
C) The site may proceed with the destruction of the essential documents.
D) The site should contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.

5. A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

A) They cannot be the PI on the clinical study due to conflict of interest.
B) They can attend the meeting, but should not vote/provide opinion on whether to approve the study.
C) They must recuse themselves from the meeting given their dual roles as IRB/IEC member and PI.
D) They can attend the meeting and can vote/provide opinion on whether to approve the study.

Solutions: