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ACRP Certified Professional Sample Questions:

1. When determining whether a protocol deviation (PD) is reportable to the IRB/IEC, the PI should take into consideration whether the:

A) Sponsor approved the PD.
B) PD affected participant recruitment.
C) PD affected participant safety.
D) Participant verbally agreed to the PD.

2. A protocol amendment is needed to collect additional data from a participant's medical record. When can the research team begin collecting the additional data?

A) When the need for the additional data is discovered
B) After the original planned data collection is completed
C) After the protocol amendment is approved by the IRB/IEC
D) As soon as the protocol amendment is submitted to the IRB/IEC

3. In an investigator-initiated study, who is responsible for implementing appropriate corrective and preventive actions when significant non-compliance is discovered?

A) CRC
B) PI
C) CRA
D) IRB/IEC

4. A site is starting up a Phase III trial. They have received IRB/IEC approval and have scheduled the SIV. The site cannot begin enrolling subjects until:

A) The CRA has performed source document review and verification at the site.
B) The DSMB meets and the first DSMB meeting report has been issued.
C) The site receives approval from the medical monitor to begin enrolling.
D) A signed clinical trial agreement between the site and sponsor is in place.

5. In a quality management system, in which category do risk reduction activities belong?

A) Risk Evaluation
B) Risk Review
C) Risk Communication
D) Risk Control

Solutions: