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ACRP Certified Professional Sample Questions:

1. A protocol inclusion criterion requires the serum magnesium at screening to be within the normal range. After the subject received IP, the CRC discovers the subject's screening magnesium level was below the normal range and the sub-investigator marked the lab sheet as not clinically significant. Which of the following should be done FIRST?

A) Notify the subject.
B) Withdraw the subject.
C) Notify the sponsor.
D) Notify the regulatory authority.

2. The IB contains which of the following sections?

A) Participant dosing schedule
B) IP preparation instructions
C) Participant eligibility criteria
D) Known pharmacokinetic effects

3. While reviewing a new protocol, a PI realizes a specialized laboratory test is required that the local hospital does not perform. The PI locates a laboratory that performs the specialized test and retains their services.
Responsibility for ensuring the laboratory retained is qualified for this trial-related task lies with the:

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

4. When assessing the monitoring needs for a study, sponsors should:

A) Use central monitoring instead of conducting physical monitoring visits at sites.
B) Ensure monitoring visits are conducted at periodic intervals with a minimum of monthly monitoring visits.
C) Ensure monitors have the scientific and/or clinical knowledge needed to monitor the trial adequately.
D) Permit PIs to select a monitor for their site as long as they are independent of the PI.

5. 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 contact the sponsor and receive verbal notification they are no longer needed andthe essential documents may be destroyed.
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 retain the essential documents longer to meet the regulatory requirements.

Solutions: