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ACRP Certified Professional Sample Questions:

1. The site submitted all start-up documents for a study to the sponsor and the IRB/IEC. The site also has subjects identified for screening. What should happen FIRST?

A) Schedule a site initiation visit
B) Ship/receive IP
C) Obtain IRB/IEC approval
D) Verify subject eligibility

2. Access to study documentation for auditors and inspectors during an audit or inspection at a clinical trial site is the responsibility of the:

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

3. 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* 3 participants were withdrawn due to noncompliance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) 6 participants
B) 5 participants
C) 3 participants
D) 4 participants

4. A study drug will be shipped, stored, and mixed at the hospital pharmacy and will be transferred to the study site for infusion. Which document describes how the transfer will occur?

A) Investigator's Brochure
B) Clinical Monitoring Plan
C) Standard Operating Procedure
D) Data & Safety Monitoring Plan

5. Which of the following activities would be undertaken by the sponsor to BEST ensure overall quality of the study data?

A) Ensure submission of a data management plan to the regulatory authorities.
B) Conduct annual reviews of the protocol and accompanying study documents.
C) Develop a plan that describes the monitoring approach for a clinical study.
D) Ensure there is an accompanying written record that describes the consent process.

Solutions: