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ACRP Certified Professional Sample Questions:

1. A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

A) Protocol
B) IB
C) ICF
D) Package insert

2. A protocol requires participants to take IP for 6 months. The protocol allows for any participants who are noncompliant to be replaced by enrolling additional participants, except if it is due to an AE. The investigator has enrolled 12 participants.
The status of the enrolled participants is as follows:
* 3 participants were withdrawn due to noncompliance
* 1 participant withdrew consent after experiencing severe nausea
* 1 participant had to discontinue IP for an unscheduled hospitalization
* 1 participant who is not returning for visits
* 2 participants completed the 6 months of treatment
* 4 participants currently on IP
How many participants should be replaced?

A) 4 participants
B) 6 participants
C) 3 participants
D) 5 participants

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

4. In addition to members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial, it is recommended that the IRB/IEC should include:

A) One member who is independent of the institution/trial site.
B) A total of five members.
C) One member of the site's QA group.
D) One member whose primary area of interest is in the same scientific area.

5. A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

A) Regulatory authorities must be notified promptly of the transfer of any duties to a CRO.
B) Any trial-related duties can be documented as transferred by verbal agreement.
C) All duties transferred to a CRO should be specified in writing.
D) The IRB/IEC must approve the transfer of duties to a CRO.

Solutions: