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ACRP Certified Professional Sample Questions:

1. Which of the following elements of the Informed Consent are NOT required?

A) Statement that study involves research
B) A description of potential benefits
C) Subject legal rights can be waived
D) A description of any reasonably foreseeable risks or discomforts

2. The IRB/IEC has decided to not approve a clinical trial. Who must they notify in writing?

A) Regulatory Agency
B) PI
C) CRC
D) Sponsor

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

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

4. All site financial matters pertaining to a trial are listed in what document?

A) Informed consent form
B) Signed contract
C) Protocol
D) Financial disclosure

5. AEs that occur between study visits of a clinical trial should be evaluated by the:

A) Principal Investigator
B) Medical monitor
C) Study pharmacovigilance physician
D) Subject's primary care physician

Solutions: