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ACRP Certified Professional Sample Questions:

1. A sponsor wants a new clinical trial to be reviewed at regular intervals for progress, safety, and endpoint evaluation, and make recommendations to continue, modify, or stop the trial. How should they proceed?

A) Establish a DSMB/IDMC
B) Conduct routine investigators' meetings
C) Draft a CAPA plan
D) Develop a monitoring plan

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

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

3. A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

A) Worksheet.
B) CRF.
C) PRO.
D) Source document.

4. Which of the following should be reviewed and evaluated by qualified experts to assess implications for the safety of the trial subjects?

A) Project feasibility considerations
B) Emerging animal toxicological and clinical data
C) Sample collection storage, disposal, and shipment requirements
D) PI roles and responsibilities

5. After the site qualification visit report has been finalized, it must be:

A) Kept in the CRO/sponsor's trial master file.
B) Stored in the sponsor's budgets and contracts file.
C) Sent to the IRB/IEC for review and approval.
D) Included in the PI's regulatory file.

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