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ACRP Certified Professional Sample Questions:

1. A quality assurance audit of the EDC system SOP revealed a deficiency. Which of the following is the MOST likely reason?

A) The frequency of data backup was not defined.
B) The number of users with access was not defined.
C) The number of unique eCRF templates was not specified.
D) The list of comparable technology solutions was not included.

2. After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like to include a subject diary for each trial subject to capture their activities and experiences on the trial regimen. After the PI has generated a diary, what should the PI do next?

A) Submit the diary to the sponsor for approval.
B) Submit the diary to the regulatory authority for approval.
C) No approval is necessary: give the diary to each subject.
D) Submit the diary to the IRB/IEC for approval.

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. A written description of a trial in which the clinical and statistical description, presentations, and analyses are fully integrated into a single document is called a:

A) Clinical Study Report
B) IDMC/DSMB Report
C) Investigator Brochure
D) Clinical Study Protocol

5. Which document confirms the PI's agreement to permit auditing at the study site?

A) ICF
B) Delegation Log
C) IB
D) Protocol

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