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ACRP Certified Professional Sample Questions:

1. 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.

2. A deferred consent can take place in which of the following situations?

A) In an emergency situation only, when this process is described in the protocol and has received permission from the ethics committee.
B) In an emergency situation only, even when this process is not described in the protocol, but the sponsor approves the consent process.
C) Only when the PI approves such a consent process immediately prior to patient enrollment, regardless of the situation being classed as emergency.
D) Only when the PI approves such a consent process, regardless of the emergency situation described in the protocol.

3. The CRC is prepared to consent a cognitively impaired participant to an Alzheimer's clinical trial. The CRC is required to utilize which of the following in the consent process?

A) A legally acceptable representative
B) A family member
C) A witness
D) A member of the research team

4. In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

A) Randomization
B) Privacy controls
C) Blinding
D) Placebo-controlled

5. Confidentiality and privacy rules for protection of human subjects at research sites are determined by the:

A) Applicable regulatory authorities
B) Applicable site SOPs
C) Sponsor
D) PI

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