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ACRP ACRP-CP Exam Syllabus Topics:

ACRP Certified Professional Sample Questions:

1. A study is using an EDC system. After the data is entered into EDC, who is the next to review and conduct SDV of this data?

A) Data Manager
B) QA Department
C) Monitor
D) Sponsor

2. A trial subject was involved in a traffic accident. The emergency room (ER) doctor notifies the investigator that he wants to give the subject a blood transfusion. Blood transfusion is one of the prohibited treatments in the trial. How should the investigator respond?

A) Ask the ER doctor not to transfuse blood and consider another treatment compliant with the protocol.
B) Advise the ER doctor to transfuse blood, and the PI should withdraw the subject from the trial.
C) Advise the ER doctor to transfuse the blood, and the PI should report this incident to the sponsor.
D) Report this incident immediately to the sponsor and leave the treatment decision to them.

3. The process of ensuring and documenting that an electronic data processing system conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance is called:

A) Quality Assurance
B) Quality Control
C) Validation
D) Programming

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

5. A serious unexpected ADR is one:

A) That does not need to be reported to the IRB/IEC.
B) Severity and nature of the reaction is consistent with protocol.
C) Where the severity of the reaction is not consistent with IB.
D) That results in the death of the subject.

Solutions: